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vMap Control Unit VMCU1

by Vektor Medical, Inc.

vMap Control Unit VMCU1 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 13 Dec 2021 (UDI-DI 00860007954177), 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 Number00860007954177 UDI-DI Date13 Dec 2021ListedStatusListed 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 00860007954177 listed 13 Dec 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211546
  2. Listed FDA GUDID 00860007954177

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  • Withdrawn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 computer
Model / reference
VMCU1
Primary DI / UDI-DI
00860007954177
510(k) Number
FDA product code
DQK
GMDN term
Cardiac mapping system computer
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system computer

Cleared under the same submission (K211546)

Other devices from Vektor Medical, Inc.

See all devices from Vektor Medical, Inc. →

Properties

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