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510(k) K030587

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP by S-Tct Health, Inc. — Product Code DRN

K030587 is an FDA 510(k) premarket notification submitted by S-Tct Health, Inc. for the device "EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP". The FDA issued a decision of Substantially Equivalent on May 30, 2003. 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
May 30, 2003
Date Received
February 25, 2003
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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  • 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