vMap Disposables VMDISP1

by Vektor Medical, Inc.

vMap Disposables VMDISP1 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 00860007954108), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00860007954108 UDI-DI	Date13 Dec 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK211546	Date9 Nov 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00860007954108
FDA 510(k) database 510(k) number K211546

Across registries

2 registries list this device

FDA 510(k) K211546 decided 9 Nov 2021 Active
FDA GUDID UDI-DI 00860007954108 listed 13 Dec 2021 Listed

Timeline

2 dated events

9 Nov 2021 Cleared FDA 510(k) K211546
13 Dec 2021 Listed FDA GUDID 00860007954108

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: vMap Disposables
Generic name: Cardiac mapping system computer
Model / reference: VMDISP1

Primary DI / UDI-DI: 00860007954108
510(k) Number: K211546
FDA product code: DQK
GMDN term: Cardiac mapping system computer

Device class: Class II
Regulation number: 870.1425
GUDID distribution status: In Commercial Distribution

Other devices from Vektor Medical, Inc.

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Vektor Medical vMap Software vMap Software - US

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Class II
vMap Disposables VMDISP3

Class II

See all devices from Vektor Medical, Inc. →

Properties

Single use
Prescription use
Lot / batch number
Expiration date

Other properties (11, all answered No)