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510(k) K082134

CIRCULATOR BOOT by Circulator Boot Corp. — Product Code DRN

K082134 is an FDA 510(k) premarket notification submitted by Circulator Boot Corp. for the device "CIRCULATOR BOOT". The FDA issued a decision of Substantially Equivalent on May 7, 2009. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Circulator Boot Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2009
Date Received
July 29, 2008
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 Circulator Boot Corp.

  • K971026 — THE CIRCULATOR BOOT (August 14, 1997)
  • K833627 — CIRCULATOR MINIBOOT (May 23, 1984)
  • K792354 — THE CIRCULATOR BOOT (January 9, 1980)

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)
  • 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