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AngioSculpt OTW PTA Scoring Balloon Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2216-30100
Identity
- Trade Name
- AngioSculpt OTW PTA Scoring Balloon Catheter EUDAMEDAngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- AngioSculpt PTA Scoring Balloon Catheter EUDAMED
- Model / Reference
- 2216-30100 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2216-30100 FDA UDI
- Primary DI / UDI-DI
- 00813132022914 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132022914 EUDAMED
- FDA Product Code
- PNO FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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 Length — 100 Millimeter FDA UDIBalloon Diameter — 3.0 Millimeter FDA UDI
AngioSculpt OTW PTA Scoring Balloon Catheter by Spectranetics Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00813132022914 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 5db7e778-c285-4022-bf46-a3db755b9eac 61 fields · synced Jul 18, 2026
- FDA UDI 132f96fe-2754-4ef8-958a-30269ea9617f 36 fields · synced May 30, 2026