Skip to content

VX1 A001

by Substrate Hd

VX1 A001 is a Class II device made by Substrate Hd, cleared under FDA 510(k) K201298 on 16 Sep 2020 and listed in FDA GUDID since 15 Jun 2021 (UDI-DI 03770019196007), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K201298

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 Number03770019196007 UDI-DI Date15 Jun 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201298 Date16 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201298 decided 16 Sep 2020 Active
  • FDA GUDID UDI-DI 03770019196007 listed 15 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201298
  2. Listed FDA GUDID 03770019196007

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VX1
Generic name
Cardiac mapping system computer
Model / Ref / Catalog
A001
Primary DI / UDI-DI
03770019196007
FDA product code
DQK
GMDN term
Cardiac mapping system computer
Device class
Class II
Regulation number
870.1425
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Cardiac mapping system computer

Similar devices in this category

Other devices filed under Cardiac mapping system computer.

Other devices from Substrate Hd

Properties

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