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510(k) K010261

CARDIOMEDICS ECP SYSTEM by Cardiomedics, Inc. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2001
Date Received
January 29, 2001
Clearance Type
Special
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)
  • K872034 — CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM (September 18, 1987)

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