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510(k) K010261

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

K010261 is an FDA 510(k) premarket notification submitted by Cardiomedics, Inc. for the device "CARDIOMEDICS ECP SYSTEM". The FDA issued a decision of Substantially Equivalent on February 28, 2001. 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
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)

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