Skip to content

Localisa® 9670590

by Medtronic, Inc.

Localisa® 9670590 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K002869 on 27 Mar 2001 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 00643169006874), active as of 22 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 22 Oct 2026

Documents

510(k) K002869

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169006874 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002869 Date27 Mar 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002869 decided 27 Mar 2001 Active
  • FDA GUDID UDI-DI 00643169006874 listed 30 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K002869
  2. Listed FDA GUDID 00643169006874

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Localisa®
Generic name
Cardiac mapping system reference patch
Model / reference
9670590
Primary DI / UDI-DI
00643169006874
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
  • Lot / batch number
Other properties (12, all answered No)