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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, counter-pulsating, external
Regulation Description External counter-pulsating device.
Product CodeDRN
Regulation Number 870.5225
Device Class 2


Premarket Reviews
ManufacturerDecision
CIRCULATOR BOOT CORP.
  SUBSTANTIALLY EQUIVALENT 4
SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 2 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardiomedics Incorporated II Jul-07-2009
2 Philips Medical Systems (Cleveland) Inc II Jun-29-2009

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