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VivaSight Pack TVEB70100

by E.T. View Ltd

VivaSight Pack TVEB70100 is a Class II device made by E.T. View Ltd, cleared under FDA 510(k) K152438 on 25 Feb 2016 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290013745545), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290013745545 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152438 Date25 Feb 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152438 decided 25 Feb 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290013745545 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120334
  2. Cleared FDA 510(k) K152438
  3. Listed FDA GUDID 07290013745545

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VivaSight Pack
Generic name
Bronchial balloon catheter
Model / Ref / Catalog
TVEB70100
Primary DI / UDI-DI
07290013745545
510(k) Number
FDA product code
CBI, BTR
GMDN term
Bronchial balloon catheter
Device class
Class II
Regulation number
868.5740, 868.5730
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic endotracheal tube, single-useBronchial balloon catheter

Cleared under the same submission (K120334)

and 3 more cleared under K120334

Cleared under the same submission (K152438)

and 7 more cleared under K152438

Similar devices

Other devices filed under FDA product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)).

Other devices from E.T. View Ltd

See all devices from E.T. View Ltd →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)