• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device clip, hemostatic
Regulation Description Implantable clip.
Product CodeMCH
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Difficult to open or close 32
Migration of device or device component 14
Break 11
Deployment issue 8
Slippage of device or device component 5
Premature deployment 4
Unintended movement 4
Dislodged or dislocated 3
Detachment of device or device component 2
Unsealed device packaging 2
Material disintegration 1
Flaked 1
Material fragmentation 1
No code available 1
Total Device Problems 89

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

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Apr-05-2016

-
-