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Cardiassist Counter Pulsation System Series 4000/5000

by Cardiomedics, Inc.

510(k) K050172

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050172 Date31 Mar 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1582-2009 FDA Unclassified (pre-2012) initiated 9 Apr 2009

    Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.

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  • Withdrawn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
DRN
Device Class
Class II
Regulation
21 CFR Part 870.5225
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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