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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reprocessed intravascular ultrasound catheter
Regulation Description Diagnostic intravascular catheter.
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product CodeOWQ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
STERILMED
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 7
Poor gas exchange 1
Deployment issue 1
Total Device Problems 9

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 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 STERILMED, INC. II Oct-09-2014

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