AngioSculpt OTW PTA Scoring Balloon Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
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
- 2216-25100 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2216-25100 FDA UDI
- Primary DI / UDI-DI
- 00813132022907 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132022907 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Balloon Length — 100 Millimeter FDA UDIBalloon Diameter — 2.5 Millimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
AngioSculpt OTW PTA Scoring Balloon Catheter by Spectranetics Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132022907 | 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 9f6f245c-0b8d-48b6-be36-cfda19fd6495 61 fields · synced Jun 19, 2026
- FDA UDI 94c3d561-45a7-4b09-923e-529b9391c4b8 36 fields · synced May 30, 2026