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AngioSculpt PTCA RX Scoring Balloon Catheter
EUDAMEDFDA UDIClass III (EU MDR)
Ref 2200-2010
Identity
- Trade Name
- AngioSculpt PTCA RX Scoring Balloon Catheter EUDAMEDFDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, cutting/scoring FDA UDI
- Device Name
- AngioSculpt PTCA RX Scoring Balloon Catheter EUDAMED2.0 mm x 10 mm FDA UDI
- Model / Reference
- 2200-2010 EUDAMEDFDA UDI
- Description
- 2.0 mm x 10 mm FDA UDI
Identifiers
- Catalog Number
- 2200-2010 FDA UDI
- Primary DI / UDI-DI
- 00813132021146 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132021146 EUDAMED
- PMA Number
- P050018 FDA UDI
- FDA Product Code
- NWX FDA UDI
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, cutting/scoring FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 2.0 Millimeter FDA UDIBalloon Length — 10 Millimeter FDA UDI
Category: Coronary angioplasty balloon catheter, cutting/scoring
AngioSculpt PTCA RX Scoring Balloon Catheter by Spectranetics Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132021146 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000023203
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (2)
- EUDAMED c3f1a7de-bb1b-4227-9bd4-8d51fcd650e4 61 fields · synced Jul 14, 2026
- FDA UDI e921006f-c996-4386-813e-0a557184fece 38 fields · synced May 30, 2026