Identity
- Trade Name
- SurVeil DCB FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
- Device Name
- SurVeil DCB 4.0mm x 40mm x 135cm FDA UDI
- Model / Reference
- SRV03513504040 FDA UDI
- Description
- SurVeil DCB 4.0mm x 40mm x 135cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812339030333 FDA UDI
- PMA Number
- P210025 FDA UDI
- FDA Product Code
- ONU FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 4 Millimeter FDA UDIBalloon Length — 40 Millimeter FDA UDICatheter Length — 135 Centimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, drug-coated
SurVeil DCB by Surmodics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, drug-coated.
- Stellarex 0.035" OTW drug-coated angioplasty balloon — Philips Image Guided Therapy Corporation · Class III
- IN.PACT™ Admiral™ — MEDTRONIC, INC. · Class III
- Ranger™ — Boston Scientific · Class III
- Lutonix® Drug Coated Balloon — Lutonix · Class III
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter — Lutonix · Class III
- Stellarex — Philips Image Guided Therapy Corporation · Class III
- In.Pact™ 018 — MEDTRONIC, INC. · Class III
- Stellarex 0.035" OTW drug-coated angioplasty balloon — Philips Image Guided Therapy Corporation · Class III
Cleared under the same submission
P210025 also covers:
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
- SurVeil DCB — Surmodics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Surmodics, Inc.
Sources (1)
- FDA UDI 48d52f02-4f77-4c67-8bdc-2d1380c62295 36 fields · synced Jun 6, 2026