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Achieve Advance™ 2ACH15

by Medtronic, Inc.

Ref 2ACH15

Achieve Advance™ 2ACH15 is a device classified as Class III in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00763000279998), cleared under FDA 510(k) K162892 on 15 Nov 2016 and listed in FDA GUDID since 26 Dec 2016 (UDI-DI 00763000279998), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162892

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00763000279998 Basic UDI-DI 00763000279998UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000279998 UDI-DI Date26 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK162892 Date15 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00763000279998 registered 29 Oct 2026 Active
  • FDA 510(k) K162892 decided 15 Nov 2016 Active
  • FDA GUDID UDI-DI 00763000279998 listed 26 Dec 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162892
  2. Listed FDA GUDID 00763000279998
  3. Registered EUDAMED B-00763000279998

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  • Withdrawn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

Trade name
Achieve Advance™
Generic name
Cardiac mapping catheter, percutaneous, single-use
Device name
Achieve Family Catheters
Model / reference
2ACH15
Primary DI / UDI-DI
00763000279998 EUDAMED
00643169590960 GUDID
Basic UDI-DI
B-00763000279998
510(k) Number
FDA product code
DRF
EMDN code
C02010499 Arrhythmology multipolar diagnostic catheters – other
GMDN term
Cardiac mapping catheter, percutaneous, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1220
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 165.0 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000279998
GUDID
00643169590960
Device classEUDAMED
Class III
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000279998; FDA GUDID lists 00643169590960), so their flags are not compared. Device class is stated on each registry's own scale: Class III 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: Cardiac mapping catheter, percutaneous, single-use

Cleared under the same submission (K162892)

Similar devices in this category

Other devices filed under ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)