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Fortrex™ A35HPV08100135

by Medtronic, Inc.

Ref A35HPV08100135

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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/MDR EUDAMED Number0763000B00002036W Basic UDI-DI 00763000634773UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000634773 UDI-DI Date15 Feb 2024ListedStatusListed GUDID: 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Fortrex™
Generic Name
Peripheral angioplasty balloon catheter, basic
Device Name
Fortrex
Model / Reference
A35HPV08100135
Primary DI / UDI-DI
00763000634773
Basic UDI-DI
0763000B00002036W
510(k) Number
FDA Product Code
LIT
EMDN Code
C010402020101 PTA balloon dilatation catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 8.0 Millimeter
Length — 135.0 Centimeter
Catheter Gauge — 6.0 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Cleared under the same submission (K142654)

Show all (12)

Other devices from Medtronic, Inc.

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Properties

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

Other properties (20)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No