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510(k) K022107

CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 by Cardiomedics, Inc. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2002
Date Received
June 28, 2002
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)
  • K010261 — CARDIOMEDICS ECP SYSTEM (February 28, 2001)
  • K872034 — CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM (September 18, 1987)

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  • K152115 — Renew NCP-5 External Counterpulsation System (December 17, 2015)
  • K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (December 12, 2013)
  • K082134 — CIRCULATOR BOOT (May 7, 2009)
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  • K052611 — ECP HEALTH SYSTEM, MODEL 2005 (April 26, 2006)