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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device angiography/angioplasty kit
Regulation Description Angiographic injector and syringe.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEQ
Regulation Number 870.1650
Device Class 2

Device Problems
Break 1
Fracture 1
Loose or intermittent connection 1
Connection issue 1
Item contaminated during manufacturing or shipping 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 2 0 0
Class II 0 0 0 0 0 0 0 0 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015
3 Customed, Inc I Dec-16-2014
4 Customed, Inc I Aug-29-2014
5 Navilyst Medical, Inc II Feb-26-2015

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