Identity
- Trade Name
- SurVeil Drug-Coated Balloon FDA PMA
- Generic Name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter FDA PMA
Identifiers
- PMA Number
- P210025 FDA PMA
- FDA Product Code
- ONU FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The SurVeil Drug-Coated Balloon is a drug-eluting peripheral transluminal angioplasty catheter designed for cardiovascular interventions. It is indicated for use in percutaneous transluminal angioplasty of de novo or restenotic lesions in the femoral and popliteal arteries.
This device is intended for lesions up to 180 mm in length within vessels having reference diameters between 4 mm and 7 mm. The catheter is used following appropriate vessel preparation to ensure optimal clinical outcomes. It has received FDA premarket approval for its intended use in peripheral vascular procedures.
Frequently asked questions
What is the primary use of the SurVeil Drug-Coated Balloon?
The device is indicated for percutaneous transluminal angioplasty to treat de novo or restenotic lesions in the femoral and popliteal arteries.
What vessel sizes is this balloon catheter designed to treat?
The SurVeil Drug-Coated Balloon is indicated for use in arteries with reference vessel diameters ranging from 4 mm to 7 mm.
Are there limitations on the lesion length for this device?
Yes, the device is indicated for the treatment of lesions that are 180 mm or less in length.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P210025 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surmodics, Inc.
- FDA Applicant
- Surmodics,Inc.
Sources (1)
- FDA PMA P210025 24 fields · synced Sep 18, 2026