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Cardio-Pak Basic Pump Pack

by Cardio-Med-Associates, Inc.

510(k) K923231

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)SESK Substantially Equivalent — Kit · Traditional NumberK923231 Date9 Jul 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0753-03 FDA Unclassified (pre-2012) initiated 25 Mar 2003 on shared 510(k) K923231

    Product has latex free symbol on package, yet contains latex components.

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  • Withdrawn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

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