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EnSite Precision™ H702701

by St. Jude Medical, Inc.

EnSite Precision™ H702701 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K201148 on 26 Jun 2020 (1 earlier submission) and listed in FDA GUDID since 3 Jun 2022 (UDI-DI 05415067035004), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05415067035004 UDI-DI Date3 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201148 Date26 Jun 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201148 decided 26 Jun 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05415067035004 listed 3 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201148
  2. Cleared FDA 510(k) K201181
  3. Listed FDA GUDID 05415067035004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EnSite Precision™
Generic name
Cardiac mapping system application software
Model / Ref / Catalog
H702701
Primary DI / UDI-DI
05415067035004
510(k) Number
FDA product code
DQK
GMDN term
Cardiac mapping system application software
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system application software

Cleared under the same submission (K201148)

Cleared under the same submission (K201181)

and 8 more cleared under K201181

Similar devices

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

Other devices from St. Jude Medical, Inc.

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

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)