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ATL2001

by Medtronic, Inc.

Ref ATL2001

ATL2001 is a medical device (EU MDD Class IIa; FDA Class II; FDA product code CAC, Apparatus, Autotransfusion) made by Medtronic, Inc., registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI B-00613994520456), cleared under FDA 510(k) K093535 on 22 Mar 2010 and listed in FDA GUDID since 9 Jun 2015 (UDI-DI 00613994520456), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093535

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00613994520456 Basic UDI-DI 00613994520456UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00613994520456 UDI-DI Date9 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093535 Date22 Mar 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00613994520456 registered 12 Aug 2026 Active
  • FDA 510(k) K093535 decided 22 Mar 2010 Active
  • FDA GUDID UDI-DI 00613994520456 listed 9 Jun 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093535
  2. Listed FDA GUDID 00613994520456
  3. Registered EUDAMED B-00613994520456

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Autotransfusion system blood component processing set
Device name
Wash Kit
Model / reference
ATL2001
Primary DI / UDI-DI
00613994520456
Basic UDI-DI
B-00613994520456
510(k) Number
FDA product code
CAC
EMDN code
B0402 Intra- and postoperative blood collection and reinfusion only devices and kits
GMDN term
Autotransfusion system blood component processing set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5830
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Autotransfusion system blood component processing set

Cleared under the same submission (K093535)

and 2 more cleared under K093535

Similar devices in this category

Other devices filed under AUTOTRANSFUSION DEVICES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (20, all answered No)