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510(k) K152115

Renew NCP-5 External Counterpulsation System by Stage 2 Innovations — Product Code DRN

K152115 is an FDA 510(k) premarket notification submitted by Stage 2 Innovations for the device "Renew NCP-5 External Counterpulsation System". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
July 29, 2015
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

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  • 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)
  • 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)
  • K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (March 31, 2005)

FDA data resources