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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, aneurysm
Regulation Description Aneurysm clip.
Product CodeHCH
Regulation Number 882.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 10
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 4
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MIZUHO
  SUBSTANTIALLY EQUIVALENT 2
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 7
Difficult to open or close 2
Material deformation 2
Slippage of device or device component 2
Use of Device Issue 1
Improper or incorrect procedure or method 1
Defective item 1
Deployment issue 1
No Information 1
Loose or intermittent connection 1
Mechanical issue 1
Total Device Problems 20

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

Recalls
Manufacturer Recall Class Date Posted
1 Mizuho America, Inc. II Nov-22-2013

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