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Afr-00021

by Medtronic, Inc.

Afr-00021 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K243435 on 5 Dec 2024 and listed in FDA GUDID since 15 Aug 2025 (UDI-DI 00763000980115), 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) K243435

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 Number00763000980115 UDI-DI Date15 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK243435 Date5 Dec 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243435 decided 5 Dec 2024 Active
  • FDA GUDID UDI-DI 00763000980115 listed 15 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243435
  2. Listed FDA GUDID 00763000980115

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  • Withdrawn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 reference patch
Model / reference
AFR-00021
Description
MAGNETIC PATCH AFR-00021
Primary DI / UDI-DI
00763000980115
510(k) Number
FDA product code
DQK
GMDN term
Cardiac mapping system reference patch
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system reference patch

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (11, all answered No)