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MediGuide™ Technology

by St. Jude Medical, Inc. 28 variants

MediGuide™ Technology (H700669) is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K120301 on 24 Feb 2012 and listed in FDA GUDID since 29 Mar 2016 (UDI-DI 05415067006691), 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) K120301

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 Number05415067006691 UDI-DI Date29 Mar 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK120301 Date24 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120301 decided 24 Feb 2012 Active
  • FDA GUDID UDI-DI 05415067006691 listed 29 Mar 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120301
  2. Listed FDA GUDID 05415067006691

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MediGuide™
Generic name
Cardiac mapping system
Model / Ref / Catalog
Technology, H700669
Primary DI / UDI-DI
05415067006691
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

Category: Cardiac mapping system

Cleared under the same submission (K120301)

and 8 more cleared under K120301

Similar devices in this category

Other devices filed under Cardiac mapping system.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)