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Oz Power Syringe

by Cardiovascular Innovations

510(k) K973334

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK973334 Date3 Apr 1998ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1529-2021 FDA Class II initiated 6 Apr 2021

    The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

    • Terminated Z-0008-2008 FDA Unclassified (pre-2012) initiated 18 Jul 2007

    Sterility of device may be compromised due to breach in sterile barrier.

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  • Withdrawn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
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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