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Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16

by St. Jude Medical, Inc.

Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K251211 on 23 May 2025 (2 earlier submissions) and listed in FDA GUDID since 1 May 2018 (UDI-DI 05415067028198), 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 StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK251211 Date23 May 2025DecidedStatusActive
United StatesGUDID listing Number05415067028198 UDI-DI Date1 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251211 decided 23 May 2025 Active· +2 more in the status table
  • FDA GUDID UDI-DI 05415067028198 listed 1 May 2018 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K172393
  2. Listed FDA GUDID 05415067028198
  3. Cleared FDA 510(k) K202066
  4. Cleared FDA 510(k) K251211

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Advisor™ HD Grid, Sensor Enabled™
Generic name
Cardiac mapping catheter, percutaneous, single-use
Model / Ref / Catalog
D-AVHD-DF16
Primary DI / UDI-DI
05415067028198
510(k) Number
FDA product code
DRF, MTD
GMDN term
Cardiac mapping catheter, percutaneous, single-use
Device class
Class II
Regulation number
870.1220
GUDID distribution status
In Commercial Distribution
Size
Length — 110.0000 Centimeter
Catheter Gauge — 8.0000 French

Related devices

Category: Cardiac mapping catheter, percutaneous, single-use

Cleared under the same submission (K202066)

and 8 more cleared under K202066

Cleared under the same submission (K251211)

Similar devices in this category

Other devices filed under Cardiac mapping catheter, percutaneous, single-use.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)