Identity
- Trade Name
- Stellarex FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
- Device Name
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm FDA UDI
- Model / Reference
- AB35SX050080080 FDA UDI
- Description
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm FDA UDI
Identifiers
- Catalog Number
- AB35SX050080080 FDA UDI
- Primary DI / UDI-DI
- 00813132023126 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
No
FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 5 Millimeter FDA UDIBalloon Length — 80 Millimeter FDA UDICatheter Length — 80 Centimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, drug-coated
Stellarex by Spectranetics Corporation — 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
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
- Spectranetics Corporation
Sources (1)
- FDA UDI 9dc025d4-d81d-4284-8814-a384b2ba5bd9 37 fields · synced Jun 1, 2026