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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, pressure monitoring, cardiac
Regulation Description Diagnostic intravascular catheter.
Definition To measure pressure within the cardiovascular system.
Product CodeOBI
Regulation Number 870.1200
Device Class 2

Device Problems
No Known Device Problem 3
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Apr-03-2014

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