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VPS Rhythm Device with TipTracker Technology

by Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)

510(k) K160925

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK160925 Date22 Dec 2016ClearedStatusActive

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-0004-2024 FDA Class I initiated 10 Aug 2023

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

  • 3 recalls, same reason

    • Terminated Z-2383-2018 FDA Class II initiated 17 May 2018
    • Terminated Z-2384-2018 FDA Class II initiated 17 May 2018
    • Terminated Z-2382-2018 FDA Class II initiated 17 May 2018

    Product pouch label may not easily identify the lot number, expiration date and associated symbols..

  • 3 recalls, same reason

    • Terminated Z-2028-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2026-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2027-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

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  • Withdrawn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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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