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vMap Control Unit VMCU2

by Vektor Medical, Inc.

vMap Control Unit VMCU2 is a Class II device made by Vektor Medical, Inc., cleared under FDA 510(k) K211546 on 9 Nov 2021 and listed in FDA GUDID since 15 Nov 2022 (UDI-DI 00860007954122), 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) K211546

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 Number00860007954122 UDI-DI Date15 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211546 Date9 Nov 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211546 decided 9 Nov 2021 Active
  • FDA GUDID UDI-DI 00860007954122 listed 15 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211546
  2. Listed FDA GUDID 00860007954122

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
vMap Control Unit
Generic name
Cardiac mapping system workstation
Model / reference
VMCU2
Primary DI / UDI-DI
00860007954122
510(k) Number
FDA product code
DQK
GMDN term
Cardiac mapping system workstation
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system workstation

Cleared under the same submission (K211546)

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

Other devices from Vektor Medical, Inc.

See all devices from Vektor Medical, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)