Identity
- Trade Name
- AngioSculpt RX PTCA FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, cutting/scoring FDA UDI
- Device Name
- AngioSculpt RX PTCA Scoring Balloon Catheter, 3.0 mm x 20 mm FDA UDI
- Model / Reference
- 2200-3020 FDA UDI
- Description
- AngioSculpt RX PTCA Scoring Balloon Catheter, 3.0 mm x 20 mm FDA UDI
Identifiers
- Catalog Number
- 2200-3020 FDA UDI
- Primary DI / UDI-DI
- 00813132022051 FDA UDI
- PMA Number
- P050018 FDA UDI
- FDA Product Code
- NWX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, cutting/scoring 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
No
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 — 3.0 Millimeter FDA UDIBalloon Length — 20 Millimeter FDA UDI
Category: Coronary angioplasty balloon catheter, cutting/scoring
AngioSculpt RX PTCA by Spectranetics Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Cleared under the same submission
P050018 also covers:
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
- AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy Corporation
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 d400fd1d-5107-4b29-ac6c-f85168914bc5 38 fields · synced Jun 1, 2026