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VantageView™ VS100006

by St. Jude Medical, Inc.

VantageView™ VS100006 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K110085 on 26 Jan 2011 and listed in FDA GUDID since 28 Mar 2016 (UDI-DI 05415067010872), 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) K110085

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 Number05415067010872 UDI-DI Date28 Mar 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110085 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110085 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI 05415067010872 listed 28 Mar 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110085
  2. Listed FDA GUDID 05415067010872

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VantageView™
Generic name
Image display unit, colour
Model / Ref / Catalog
VS100006
Primary DI / UDI-DI
05415067010872
510(k) Number
FDA product code
DXJ
GMDN term
Image display unit, colour
Device class
Class II
Regulation number
870.2450
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)