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Afr-00013

by Medtronic, Inc.

Afr-00013 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K233943 on 8 Mar 2024 and listed in FDA GUDID since 14 Nov 2025 (UDI-DI 00763000998394), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K233943

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000998394 UDI-DI Date14 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK233943 Date8 Mar 2024IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233943 decided 8 Mar 2024 Active
  • FDA GUDID UDI-DI 00763000998394 listed 14 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233943
  2. Listed FDA GUDID 00763000998394

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Cardiac mapping system
Model / reference
AFR-00013
Primary DI / UDI-DI
00763000998394
510(k) Number
FDA product code
DQK
GMDN term
Cardiac mapping system
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233943)

Similar devices

Other devices filed under FDA product code DQK (Computer, diagnostic, programmable).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)