Angioplasty balloons
Opta
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
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Where to buy Opta
Contact Cordis US Corp. directly; they can quote, ship, or point you to the distributor for your country.
From cordis.com, checked October 2026.
No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.
Opta 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 |
|---|---|---|---|
| 4193080L | Length 110 cm | Not stated | Available |
| 4194000S | — | Not stated | Available |
| 4194080S | — | Not stated | Available |
| 4195000S | — | Not stated | Available |
| 4197000S | — | Not stated | Available |
| 4198000S | — | Not stated | Available |
FDA clearances
- 510(k) K032737 October 2003
Procedures that use angioplasty balloons
Frequently asked questions
What is Opta used for?
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Who makes Opta?
Opta is made by Cordis US Corp.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Opta come in?
Sizes listed for Opta: Length: 110 cm. Confirm availability with the manufacturer's instructions for use.
Is Opta MRI safe?
The FDA device database entry for Opta does not state its MRI safety status. Check the labeling before MRI.
Is Opta FDA cleared?
Opta is covered by FDA submission K032737.
How do I contact a Cordis US Corp. sales representative?
Cordis US Corp. has not listed representatives on LA Vascular yet. Visit the Cordis US Corp. 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.