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Optima Coil System

by Balt USA LLC

A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

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Optima Coil System models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
OPTI0101CSS10— MR ConditionalAvailable
OPTI0101CSS10— MR ConditionalAvailable
OPTI0101HSS10— MR ConditionalAvailable
OPTI0101HSS10— MR ConditionalAvailable
OPTI0101HSSMX— MR ConditionalAvailable
OPTI0102CSS10— MR ConditionalAvailable
OPTI0102CSS10— MR ConditionalAvailable
OPTI0102HSS10— MR ConditionalAvailable
OPTI0102HSS10— MR ConditionalAvailable
OPTI0102HSSMX— MR ConditionalAvailable
OPTI0103BLK— MR ConditionalAvailable
OPTI0103CSS10— MR ConditionalAvailable
OPTI0103CSS10— MR ConditionalAvailable
OPTI0103CSSMX— MR ConditionalAvailable
OPTI0103HSS10— MR ConditionalAvailable
OPTI0103HSS10— MR ConditionalAvailable
OPTI0103HSSMX— MR ConditionalAvailable
OPTI0104CSS10— MR ConditionalAvailable
OPTI0104CSS10— MR ConditionalAvailable
OPTI0104HSS10— MR ConditionalAvailable
OPTI0104HSS10— MR ConditionalAvailable
OPTI0151HSS10— MR ConditionalAvailable
OPTI0151HSS10— MR ConditionalAvailable
OPTI0152CSS10— MR ConditionalAvailable
OPTI0152CSS10— MR ConditionalAvailable
OPTI0152CSSMX— MR ConditionalAvailable
OPTI0152HSS10— MR ConditionalAvailable
OPTI0152HSS10— MR ConditionalAvailable
OPTI0153BLK— MR ConditionalAvailable
OPTI0153BLKT— MR ConditionalAvailable
OPTI0153CSS10— MR ConditionalAvailable
OPTI0153CSS10— MR ConditionalAvailable
OPTI0153CSSMX— MR ConditionalAvailable
OPTI0153HSS10— MR ConditionalAvailable
OPTI0153HSS10— MR ConditionalAvailable
OPTI0154CSS10— MR ConditionalAvailable
OPTI0154CSS10— MR ConditionalAvailable
OPTI0154HSS10— MR ConditionalAvailable
OPTI0154HSS10— MR ConditionalAvailable
OPTI0156BLK— MR ConditionalAvailable
OPTI0158BLK— MR ConditionalAvailable
OPTI0158BLK— MR ConditionalAvailable
OPTI0201HSS10— MR ConditionalAvailable
OPTI0201HSS10— MR ConditionalAvailable
OPTI0202CSS10— MR ConditionalAvailable
OPTI0202CSS10— MR ConditionalAvailable
OPTI0202CSSMX— MR ConditionalAvailable
OPTI0202HSS10— MR ConditionalAvailable
OPTI0202HSS10— MR ConditionalAvailable
OPTI0203CSF10— MR ConditionalAvailable
OPTI0203CSF10— MR ConditionalAvailable
OPTI0203CSS10— MR ConditionalAvailable
OPTI0203CSS10— MR ConditionalAvailable
OPTI0203HSS10— MR ConditionalAvailable
OPTI0203HSS10— MR ConditionalAvailable
OPTI0204BLK— MR ConditionalAvailable
OPTI0204CSF10— MR ConditionalAvailable
OPTI0204CSF10— MR ConditionalAvailable
OPTI0204CSS10— MR ConditionalAvailable
OPTI0204CSS10— MR ConditionalAvailable
OPTI0204HSS10— MR ConditionalAvailable
OPTI0204HSS10— MR ConditionalAvailable
OPTI0206BLKT— MR ConditionalAvailable
OPTI0206CSF10— MR ConditionalAvailable
OPTI0206CSF10— MR ConditionalAvailable
OPTI0206CSS10— MR ConditionalAvailable
OPTI0206CSS10— MR ConditionalAvailable
OPTI0206HSS10— MR ConditionalAvailable
OPTI0206HSS10— MR ConditionalAvailable
OPTI0208CSF10— MR ConditionalAvailable
OPTI0208CSF10— MR ConditionalAvailable
OPTI0208CSS10— MR ConditionalAvailable
OPTI0208CSS10— MR ConditionalAvailable
OPTI0208HSS10— MR ConditionalAvailable
OPTI0208HSS10— MR ConditionalAvailable
OPTI0208HSSMX— MR ConditionalAvailable
OPTI0210CSS10— MR ConditionalAvailable
OPTI0212BLK— MR ConditionalAvailable
OPTI0220BLK— MR ConditionalAvailable
OPTI0253CSS10— MR ConditionalAvailable
OPTI0253CSS10— MR ConditionalAvailable
OPTI0253HSS10— MR ConditionalAvailable
OPTI0253HSS10— MR ConditionalAvailable
OPTI0254CSS10— MR ConditionalAvailable
OPTI0254CSS10— MR ConditionalAvailable
OPTI0254HSS10— MR ConditionalAvailable
OPTI0254HSS10— MR ConditionalAvailable
OPTI0255CSF10— MR ConditionalAvailable
OPTI0255CSF10— MR ConditionalAvailable
OPTI0255HSSMX— MR ConditionalAvailable
OPTI0256CSS10— MR ConditionalAvailable
OPTI0256CSS10— MR ConditionalAvailable
OPTI0256HSS10— MR ConditionalAvailable
OPTI0256HSS10— MR ConditionalAvailable
OPTI0258BLK— MR ConditionalAvailable
OPTI0258BLK— MR ConditionalAvailable
OPTI0258CSS10— MR ConditionalAvailable
OPTI0258CSS10— MR ConditionalAvailable
OPTI0304CSS10— MR ConditionalAvailable
OPTI0304CSS10— MR ConditionalAvailable
OPTI0304HSF10— MR ConditionalAvailable
OPTI0304HSF10— MR ConditionalAvailable
OPTI0304HSS10— MR ConditionalAvailable
OPTI0304HSS10— MR ConditionalAvailable
OPTI0306CSF10— MR ConditionalAvailable
OPTI0306CSF10— MR ConditionalAvailable
OPTI0306CSS10— MR ConditionalAvailable
OPTI0306CSS10— MR ConditionalAvailable
OPTI0306CST10— MR ConditionalAvailable
OPTI0306CST10— MR ConditionalAvailable
OPTI0306HSF10— MR ConditionalAvailable
OPTI0306HSF10— MR ConditionalAvailable
OPTI0306HSS10— MR ConditionalAvailable
OPTI0306HSS10— MR ConditionalAvailable
OPTI0308CSF10— MR ConditionalAvailable
OPTI0308CSF10— MR ConditionalAvailable
OPTI0308CSS10— MR ConditionalAvailable
OPTI0308CSS10— MR ConditionalAvailable
OPTI0308CST10— MR ConditionalAvailable
OPTI0308HSF10— MR ConditionalAvailable
OPTI0308HSF10— MR ConditionalAvailable
OPTI0308HSS10— MR ConditionalAvailable
OPTI0308HSS10— MR ConditionalAvailable
OPTI0310BLK— MR ConditionalAvailable
OPTI0310BLK— MR ConditionalAvailable
OPTI0310CSF10— MR ConditionalAvailable
OPTI0310CSF10— MR ConditionalAvailable
OPTI0310CSS10— MR ConditionalAvailable
OPTI0310CSS10— MR ConditionalAvailable
OPTI0310HSF10— MR ConditionalAvailable
OPTI0310HSF10— MR ConditionalAvailable
OPTI0310HSS10— MR ConditionalAvailable
OPTI0310HSS10— MR ConditionalAvailable
OPTI0315HSSMX— MR ConditionalAvailable
OPTI0355CSSMX— MR ConditionalAvailable
OPTI0356CSF10— MR ConditionalAvailable
OPTI0356CSF10— MR ConditionalAvailable
OPTI0356CSS10— MR ConditionalAvailable
OPTI0356CSS10— MR ConditionalAvailable
OPTI0358CSS10— MR ConditionalAvailable
OPTI0358CSS10— MR ConditionalAvailable
OPTI0358CSSMX— MR ConditionalAvailable
OPTI0404CSFMX— MR ConditionalAvailable
OPTI0406CSS10— MR ConditionalAvailable
OPTI0406CSS10— MR ConditionalAvailable
OPTI0406HSF10— MR ConditionalAvailable
OPTI0406HSF10— MR ConditionalAvailable
OPTI0406HSS10— MR ConditionalAvailable
OPTI0406HSS10— MR ConditionalAvailable
OPTI0407CSF10— MR ConditionalAvailable
OPTI0407CSF10— MR ConditionalAvailable
OPTI0407CST10— MR ConditionalAvailable
OPTI0408CSS10— MR ConditionalAvailable
OPTI0408CSS10— MR ConditionalAvailable
OPTI0408HSF10— MR ConditionalAvailable
OPTI0408HSF10— MR ConditionalAvailable
OPTI0408HSS10— MR ConditionalAvailable
OPTI0408HSS10— MR ConditionalAvailable
OPTI0410CSF10— MR ConditionalAvailable
OPTI0410CSFMX— MR ConditionalAvailable
OPTI0410CSS10— MR ConditionalAvailable
OPTI0410CSS10— MR ConditionalAvailable
OPTI0410HSF10— MR ConditionalAvailable
OPTI0410HSF10— MR ConditionalAvailable
OPTI0410HSS10— MR ConditionalAvailable
OPTI0410HSS10— MR ConditionalAvailable
OPTI0412CSS10— MR ConditionalAvailable
OPTI0412HSFMX— MR ConditionalAvailable
OPTI0413CSF10— MR ConditionalAvailable
OPTI0413CSF10— MR ConditionalAvailable
OPTI0413CSFMX— MR ConditionalAvailable
OPTI0413CST10— MR ConditionalAvailable
OPTI0413CST10— MR ConditionalAvailable
OPTI0417CSF10— MR ConditionalAvailable
OPTI0417CSF10— MR ConditionalAvailable
OPTI0420BLK— MR ConditionalAvailable
OPTI0420HSF10— MR ConditionalAvailable
OPTI0420HSF10— MR ConditionalAvailable
OPTI0420HSSMX— MR ConditionalAvailable
OPTI0427BLK— MR ConditionalAvailable
OPTI0435BLK— MR ConditionalAvailable
OPTI0435BLK— MR ConditionalAvailable
OPTI0506HSF10— MR ConditionalAvailable
OPTI0506HSF10— MR ConditionalAvailable
OPTI0506HSS10— MR ConditionalAvailable
OPTI0506HSS10— MR ConditionalAvailable
OPTI0508CSS10— MR ConditionalAvailable
OPTI0508CSS10— MR ConditionalAvailable
OPTI0508HSF10— MR ConditionalAvailable
OPTI0508HSF10— MR ConditionalAvailable
OPTI0508HSS10— MR ConditionalAvailable
OPTI0508HSS10— MR ConditionalAvailable
OPTI0509CSF10— MR ConditionalAvailable
OPTI0509CSF10— MR ConditionalAvailable
OPTI0509CST10— MR ConditionalAvailable
OPTI0510COM18— MR ConditionalAvailable
OPTI0510CSS10— MR ConditionalAvailable
OPTI0510CSS10— MR ConditionalAvailable
OPTI0510HSF10— MR ConditionalAvailable
OPTI0510HSF10— MR ConditionalAvailable
OPTI0510HSS10— MR ConditionalAvailable
OPTI0510HSS10— MR ConditionalAvailable
OPTI0513CSS10— MR ConditionalAvailable
OPTI0513CSS10— MR ConditionalAvailable
OPTI0515HSFMX— MR ConditionalAvailable
OPTI0517BLK— MR ConditionalAvailable
OPTI0517BLK— MR ConditionalAvailable
OPTI0517CSF10— MR ConditionalAvailable
OPTI0517CSF10— MR ConditionalAvailable
OPTI0517CST10— MR ConditionalAvailable
OPTI0517CST10— MR ConditionalAvailable
OPTI0520CSF10— MR ConditionalAvailable
OPTI0530BLK— MR ConditionalAvailable
OPTI0606HSF10— MR ConditionalAvailable
OPTI0606HSF10— MR ConditionalAvailable
OPTI0608HSF10— MR ConditionalAvailable
OPTI0608HSF10— MR ConditionalAvailable
OPTI0610HSF10— MR ConditionalAvailable
OPTI0610HSF10— MR ConditionalAvailable
OPTI0610HSF10— MR ConditionalAvailable
OPTI0611CSF10— MR ConditionalAvailable
OPTI0611CSF10— MR ConditionalAvailable
OPTI0611CSFMX— MR ConditionalAvailable
OPTI0611CST10— MR ConditionalAvailable
OPTI0611CST10— MR ConditionalAvailable
OPTI0615CSF10— MR ConditionalAvailable
OPTI0615CSF10— MR ConditionalAvailable
OPTI0615CSFMX— MR ConditionalAvailable
OPTI0615HST10— MR ConditionalAvailable
OPTI0615HST10— MR ConditionalAvailable
OPTI0620COM18— MR ConditionalAvailable
OPTI0620COM18— MR ConditionalAvailable
OPTI0620CSF10— MR ConditionalAvailable
OPTI0620CSF10— MR ConditionalAvailable
OPTI0620CSFMX— MR ConditionalAvailable
OPTI0620CST10— MR ConditionalAvailable
OPTI0620CST10— MR ConditionalAvailable
OPTI0620HSFMX— MR ConditionalAvailable
OPTI0620HST10— MR ConditionalAvailable
OPTI0620HST10— MR ConditionalAvailable
OPTI0650BLK— MR ConditionalAvailable
OPTI0650BLK— MR ConditionalAvailable
OPTI0713CSF10— MR ConditionalAvailable
OPTI0713CSF10— MR ConditionalAvailable
OPTI0713CST10— MR ConditionalAvailable
OPTI0713CST10— MR ConditionalAvailable
OPTI0720BLK— MR ConditionalAvailable
OPTI0720CSFMX— MR ConditionalAvailable
OPTI0720HSFMX— MR ConditionalAvailable
OPTI0720HST10— MR ConditionalAvailable

FDA clearances

  • 510(k) K252700 September 2025
  • 510(k) K242582 September 2024
  • 510(k) K223386 December 2022
  • 510(k) K200030 February 2020
  • 510(k) K172390 February 2018

Procedures that use coils

Uterine Artery Embolization (UAE)Prostate Artery Embolization (PAE)Ovarian Vein EmbolizationVaricocele EmbolizationPortal Vein EmbolizationTIPS (Transjugular Intrahepatic Portosystemic Shunt)Brain Aneurysm CoilingAVM EmbolizationGI Bleed EmbolizationBronchial Artery EmbolizationGastroduodenal Artery (GDA) Embolization for Upper GI BleedingAneurysm and Pseudoaneurysm EmbolizationInternal Iliac Artery EmbolizationSplenic Artery Embolization

Frequently asked questions

What is Optima Coil System used for?

A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Who makes Optima Coil System?

Optima Coil System is made by Balt USA LLC. It is listed under embolization coils in our device library.

What sizes does Optima Coil System come in?

The FDA device database does not list sizes for Optima Coil System. Check the instructions for use or ask a Balt USA LLC representative.

Is Optima Coil System MRI safe?

The FDA device database lists Optima Coil System as MR Conditional. Always follow the specific MRI conditions in the labeling.

Is Optima Coil System FDA cleared?

Optima Coil System is covered by FDA submissions K172390, K200030, K242582, K252700, K223386.

How do I contact a Balt USA LLC sales representative?

Balt USA LLC has not listed representatives on LA Vascular yet. Visit the Balt USA LLC company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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