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510(k) K050172

CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 by Cardiomedics, Inc. — Product Code DRN

K050172 is an FDA 510(k) premarket notification submitted by Cardiomedics, Inc. for the device "CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000". The FDA issued a decision of Substantially Equivalent on March 31, 2005. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Cardiomedics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2005
Date Received
January 26, 2005
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.

  • 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)
  • K872034 — CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM (September 18, 1987)

Other clearances for product code DRN

  • K250756 — Pression Wave PRO External Counter-Pulsation System (December 22, 2025)
  • K202108 — External Counterpulsation System, Soulaire (August 28, 2020)
  • K191955 — Enhanced External Counter Pulsation Device Plus Omay-A (August 5, 2020)
  • K190683 — External Counterpulsation System (September 10, 2019)
  • K173483 — Pure Flow External Counter-Pulsation Device (May 30, 2018)
  • 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)
  • K081359 — GENESIS ECP (May 29, 2008)
  • K052611 — ECP HEALTH SYSTEM, MODEL 2005 (April 26, 2006)

FDA data resources