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510(k) K042413

ACS MODEL NCP-2 by Applied Cardiac Systems — Product Code DRN

K042413 is an FDA 510(k) premarket notification submitted by Applied Cardiac Systems for the device "ACS MODEL NCP-2". The FDA issued a decision of Substantially Equivalent on December 9, 2004. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Applied Cardiac Systems has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2004
Date Received
September 7, 2004
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 Applied Cardiac Systems

  • K103706 — THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR (August 24, 2011)
  • K860249 — THE HOLTER REPORTER (TM) (March 11, 1986)
  • K833823 — HOLTER PERFORMER FEATHER WEIGHT/CASS (December 1, 1983)
  • K813602 — HOLTER PERFORMER (January 29, 1982)

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