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AngioSculpt PTCA RX Scoring Balloon Catheter

EUDAMEDFDA UDI

Class III (EU MDR)

Ref 2200-3515

by Spectranetics Corporation

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 EUDAMED
3.5 mm x 15 mm FDA UDI
Model / Reference
2200-3515 EUDAMEDFDA UDI
Description
3.5 mm x 15 mm FDA UDI

Identifiers

Catalog Number
2200-3515 FDA UDI
Primary DI / UDI-DI
00813132021245 EUDAMEDFDA UDI
Basic UDI-DI
B-00813132021245 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 — 3.5 Millimeter FDA UDI
Balloon Length — 15 Millimeter FDA UDI

The AngioSculpt PTCA RX Scoring Balloon Catheter is a medical device designed for permanent circumferential revascularization in patients with critical limb ischemia. This non-invasive procedure uses cutting-edge technology to create a durable, porous tube that ensures blood flow and prevents thrombosis.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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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 c1eae9c9-bc18-4e52-b6bd-5adc67596419 61 fields · synced Jul 19, 2026
  • FDA UDI 071d42a4-b52d-4aae-a23d-630e5109e967 38 fields · synced May 30, 2026