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GORE® ACUSEAL Cardiovascular Patch 1CVX004

by W. L. Gore & Associates, Inc.

Ref 1CVX004

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00733132600915 Basic UDI-DI 00733132600915UDI-DIDate7 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00733132600915 UDI-DI Date7 Mar 2016ListedStatusListed GUDID: not in commercial distribution

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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
GORE® ACUSEAL Cardiovascular Patch
Generic Name
Cardiovascular patch, synthetic
Model / Ref / Catalog
1CVX004
Primary DI / UDI-DI
00733132600915
Basic UDI-DI
B-00733132600915
510(k) Number
FDA Product Code
DXZ
EMDN Code
P07020202 Ptfe vascular patches
GMDN Term
Cardiovascular patch, synthetic
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.3470
GUDID distribution status
Not in Commercial Distribution
Size
Height — .5 Centimeter
Width — 2.5 Centimeter
Length — 15 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Other devices from W. L. Gore & Associates, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Lot / Batch Number: No