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Vortex Medical Angiovac Cardiopulmonary Bypass Circuit

by Vortex Medical, Inc.

510(k) K092486

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK092486 Date28 Aug 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1701-2016 FDA Class II initiated 21 Mar 2016

    Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

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  • Withdrawn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
DWE
Device Class
Class II
Regulation
21 CFR Part 870.4390
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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