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Vascular Positioning System Tm (Vps Tm System) Stylet

by Vasonova, Inc.

510(k) K103255

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103255 Date18 Feb 2011ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0179-2018 FDA Class II initiated 1 Jun 2017

    There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

    • Terminated Z-2170-2017 FDA Class II initiated 28 Apr 2017

    Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.

    • Terminated Z-2462-2015 FDA Class II initiated 30 Jul 2015 on shared 510(k) K103255

    the catheter peel-away component hub tabs may prematurely detach. One injury reported.

    • Terminated Z-2489-2015 FDA Class II initiated 30 Jul 2015

    saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OBJ
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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