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Approach G50786

by Cook Incorporated

Ref CMW-14-190-6G

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number0827002CINC011-010_AF7 Basic UDI-DI 00827002507869UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002507869 UDI-DI Date24 Sep 2016ListedStatusListed 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.

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  • Withdrawn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
Approach® CTO-6 EUDAMED
Approach GUDID
Generic Name
Peripheral vascular guidewire, manual
Device Name
Approach® Micro Wire Guide [CTO-6, CTO-12, CTO-18, CTO-25]
Model / Ref / Catalog
CMW-14-190-6G, G50786
Primary DI / UDI-DI
00827002507869
Basic UDI-DI
0827002CINC011-010_AF7
FDA Product Code
PDU
EMDN Code
C04020202 Peripheral vascular therapeutic guidewires, non-hydrophilic
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CMW-14-190-6G
GUDID
G50786
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Peripheral vascular guidewire, manual

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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