Coils
i-ED COIL
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
i-ED COIL models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 371-041010 | — | MR Conditional | Available |
| 371-041015 | — | MR Conditional | Available |
| 372-041020 | — | MR Conditional | Available |
| 372-041030 | — | MR Conditional | Available |
| 373-040810 | — | MR Conditional | Available |
| 373-040815 | — | MR Conditional | Available |
| 373-040830 | — | MR Conditional | Available |
| 373-051230 | — | MR Conditional | Available |
| 373-051250 | — | MR Conditional | Available |
| 373-122050 | — | MR Conditional | Available |
| 374-142450 | — | MR Conditional | Available |
| 390-01H2 | — | MR Conditional | Available |
| 390-01H3 | — | MR Conditional | Available |
| 390-01H4 | — | MR Conditional | Available |
| 390-0101 | — | MR Conditional | Available |
| 390-0102 | — | MR Conditional | Available |
| 390-0103 | — | MR Conditional | Available |
| 390-02H4 | — | MR Conditional | Available |
| 390-02H6 | — | MR Conditional | Available |
| 390-0203 | — | MR Conditional | Available |
| 390-0204 | — | MR Conditional | Available |
| 390-0206 | — | MR Conditional | Available |
| 390-0208 | — | MR Conditional | Available |
| 390-0212 | — | MR Conditional | Available |
| 390-0304 | — | MR Conditional | Available |
| 390-0306 | — | MR Conditional | Available |
| 390-0308 | — | MR Conditional | Available |
| 392-03H8 | — | MR Conditional | Available |
| 392-0304 | — | MR Conditional | Available |
| 392-0306 | — | MR Conditional | Available |
| 392-0408 | — | MR Conditional | Available |
| 392-0410 | — | MR Conditional | Available |
| 392-0510 | — | MR Conditional | Available |
| 392-0515 | — | MR Conditional | Available |
| 392-0615 | — | MR Conditional | Available |
| 392-0620 | — | MR Conditional | Available |
| 392-0720 | — | MR Conditional | Available |
| 392-0730 | — | MR Conditional | Available |
| 392-0840 | — | MR Conditional | Available |
| 392-0940 | — | MR Conditional | Available |
| 392-1040 | — | MR Conditional | Available |
| 392-1250 | — | MR Conditional | Available |
| 392-1450 | — | MR Conditional | Available |
| 392-1650 | — | MR Conditional | Available |
| 393-020304 | — | MR Conditional | Available |
| 393-020306 | — | MR Conditional | Available |
| 393-020310 | — | MR Conditional | Available |
| 393-020320 | — | MR Conditional | Available |
| 393-020330 | — | MR Conditional | Available |
| 393-030510 | — | MR Conditional | Available |
| 393-030515 | — | MR Conditional | Available |
| 393-030520 | — | MR Conditional | Available |
| 393-030530 | — | MR Conditional | Available |
FDA clearances
- 510(k) K210638 March 2021
Procedures that use coils
Frequently asked questions
What is i-ED COIL used for?
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; 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 i-ED COIL?
i-ED COIL is made by Kaneka Corporation. It is listed under embolization coils in our device library.
What sizes does i-ED COIL come in?
The FDA device database does not list sizes for i-ED COIL. Check the instructions for use or ask a Kaneka Corporation representative.
Is i-ED COIL MRI safe?
The FDA device database lists i-ED COIL as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is i-ED COIL FDA cleared?
i-ED COIL is covered by FDA submission K210638.
How do I contact a Kaneka Corporation sales representative?
Kaneka Corporation has not listed representatives on LA Vascular yet. Visit the Kaneka Corporation 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.