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Conquest 40 PTA Dilatation Catheter

by Bard Peripheral Vascular, Inc. EUDAMED510(k)GUDID

Active European Union and United States

510(k) K120660Ref CQ7552

Overview

The Conquest 40 PTA Dilatation Catheter is a peripheral angioplasty device designed for transluminal dilation of peripheral arteries. It is classified as a catheter and falls under the nomenclature for angioplasty procedures, specifically for treating arterial stenosis or occlusion in peripheral vascular systems.

This device is intended for single-use in interventional radiology or cardiology settings. Supplied sterile, it is regulated under FDA 510(k) clearance and MDR compliance, with a traditional review pathway. The catheter is available in a specific reference code (40) and is intended for use in controlled clinical environments where peripheral vascular interventions are performed.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741EFHGJSLCM9 Basic UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741062827 UDI-DIDate19 Aug 2016ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK120660 Date15 Mar 2012ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0917-2020 FDA Class II initiated 14 Aug 2019

    The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Conquest EUDAMED
Conquest® GUDID
Generic Name
Peripheral angioplasty balloon catheter, basic
Model / Ref / Catalog
CQ7552
Primary DI / UDI-DI
00801741062827
Basic UDI-DI
0801741EFHGJSLCM9
510(k) Number
FDA Product Code
LIT 510(k)
DQY GUDID
EMDN Code
C010402020101 PTA balloon dilatation catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1250
Market of Registration
Belgium
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
n/a
510(k)
LIT
GUDID
DQY
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No