AngioSculpt OTW PTA Scoring Balloon Catheter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 2105-6040

by Spectranetics Corporation

Identity

Trade Name: AngioSculpt OTW PTA Scoring Balloon Catheter EUDAMEDFDA UDI
AngioSculpt® FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: AngioSculpt PTA Scoring Balloon Catheter EUDAMED
AngioSculpt® PTA Scoring Balloon Catheter FDA UDI
Model / Reference: 2105-6040 EUDAMEDFDA UDI
2105-6040-A FDA UDI
Description: AngioSculpt® PTA Scoring Balloon Catheter FDA UDI

Identifiers

Catalog Number: 2105-6040 FDA UDI
Primary DI / UDI-DI: 00813132021450 EUDAMEDFDA UDI
M3702105604016 FDA UDI
Basic UDI-DI: B-00813132021450 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 EUDAMED
Class 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

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 40 Millimeter FDA UDI
Outer Diameter — 6.0 Millimeter FDA UDI
Balloon Length — 40 Millimeter FDA UDI
Balloon Diameter — 6.0 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

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-00813132021450	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 (3)

EUDAMED cf92b8e0-5db3-4da3-b106-043cc8db4add 61 fields · synced Jun 18, 2026
FDA UDI c32ef4b3-0a3a-4735-80af-34d84cdd81fb 37 fields · synced May 30, 2026
FDA UDI 71d9bbcc-f84a-4ecd-8a3a-bcebf44a0039 36 fields · synced May 30, 2026