Low Profile PTA Balloon Dilatation Catheter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PTA5-35-135-6-8.0

by Cook Incorporated

Identity

Trade Name: Low Profile PTA Balloon Dilatation Catheter EUDAMED
Advance FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter EUDAMED
Advance, 35LP Low Profile PTA Balloon Dilatation Catheter FDA UDI
Model / Reference: PTA5-35-135-6-8.0 EUDAMED
G52267 FDA UDI
Description: Advance, 35LP Low Profile PTA Balloon Dilatation Catheter FDA UDI

Identifiers

Catalog Number: PTA5-35-135-6-8.0 FDA UDI
Primary DI / UDI-DI: 00827002522671 EUDAMED
10827002522678 FDA UDI
Basic UDI-DI: B-00827002522671 EUDAMED
FDA Product Code: DQY 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: Germany 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

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

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

Yes

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

Low Profile PTA Balloon Dilatation Catheter by Cook Incorporated — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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-00827002522671	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Cook Incorporated
EUDAMED SRN: US-MF-000003180
Authorised Representative: COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Sources (2)

EUDAMED 015f5633-cac0-4075-bd8f-87b31e913e52 61 fields · synced Jun 8, 2026
FDA UDI 1f66d226-88fe-4656-8dc5-dc619cc4c16f 36 fields · synced May 30, 2026