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6091-53

by Medtronic, Inc. 2 variants

Ref 6091-53

6091-53 is a device classified as Active implantable (AIMDD) (EU), Class II (US) made by Medtronic, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-00613994505309) and listed in FDA GUDID since 3 Apr 2016 (UDI-DI 00613994505309), active as of 7 Nov 2026.

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

CE AIMDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00613994505309 Basic UDI-DI 00613994505309UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00613994505309 UDI-DI Date3 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00613994505309 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00613994505309 listed 3 Apr 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00613994505309
  2. Registered EUDAMED B-00613994505309

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Pacing/defibrillation lead stylet
Device name
Stylet Kit
Model / reference
6091-53
Primary DI / UDI-DI
00613994505309
Basic UDI-DI
B-00613994505309
FDA product code
DRB
EMDN code
J01900180 Permanent cardiac leads - accessories
GMDN term
Pacing/defibrillation lead stylet
Device class
Class AIMDD EUDAMED
Class II GUDID
Regulation number
870.1380
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 53.0 Centimeter
Outer Diameter — 0.356 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class AIMDD
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class AIMDD in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pacing/defibrillation lead stylet

Similar devices

Also classified as Pacing/defibrillation lead stylet.

Similar devices in this category

Other devices filed under PERMANENT CARDIAC LEADS - ACCESSORIES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)