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Ltv 19096-001

by Vyaire Medical, Inc.

Ltv 19096-001 is a Class II device made by Vyaire Medical, Inc., cleared under FDA 510(k) K101643 on 26 Jan 2011 and listed in FDA GUDID since 4 Apr 2022 (UDI-DI 10190752115651), 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

510(k) K101643

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 Number10190752115651 UDI-DI Date4 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101643 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101643 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI 10190752115651 listed 4 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101643
  2. Listed FDA GUDID 10190752115651

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ltv
Generic name
Desk mount
Model / Ref / Catalog
19096-001
Primary DI / UDI-DI
10190752115651
510(k) Number
FDA product code
CBK
GMDN term
Desk mount
Device class
Class II
Regulation number
868.5895
GUDID distribution status
In Commercial Distribution

Related devices

Category: Desk mount

Cleared under the same submission (K101643)

and 8 more cleared under K101643

Similar devices in this category

Other devices filed under Desk mount.

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See all devices from Vyaire Medical, Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)