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510(k) K872034

CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM by Cardiomedics, Inc. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1987
Date Received
May 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

Other clearances by Cardiomedics, Inc.

  • K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (March 31, 2005)
  • K023427 — CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (January 7, 2003)
  • K022107 — CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (August 8, 2002)
  • K010261 — CARDIOMEDICS ECP SYSTEM (February 28, 2001)

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