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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instruments, surgical, cardiovascular
Regulation Description Cardiovascular surgical instruments.
Product CodeDWS
Regulation Number 870.4500
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT - KIT 3
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
SCANLAN
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Suction issue 21
Break 15
Other (for use when an appropriate device code cannot be identified) 11
Mechanical issue 9
Unknown (for use when the device problem is not known) 5
Sticking 5
Mechanical jam 4
Difficult to remove 4
Entrapment of device or device component 3
No Known Device Problem 3
Foreign material present in device 2
Deployment issue 2
Component missing 2
Device Issue 2
Tear, rip or hole in device packaging 2
Fracture 2
Detachment of device component 2
Performance 2
No Information 2
No code available 2
Product quality issue 1
Device, or device fragments remain in patient 1
Shaft break 1
Mislabeled 1
Moisture damage 1
Delivered as unsterile product 1
Material discolored 1
Device Cleaning Issue 1
Component(s), broken 1
Material fragmentation 1
Difficult to insert 1
Defective item 1
Device displays error message 1
Device, removal of (non-implant) 1
Connection issue 1
Dislodged or dislocated 1
Fail-safe mechanism issue 1
Increase in suction 1
Material integrity issue 1
Temperature issue 1
Total Device Problems 120

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

Recalls
Manufacturer Recall Class Date Posted
1 Biorep Technologies II May-02-2014
2 Edwards Lifesciences, LLC II Jun-13-2013
3 International Biophysics Corp. II Aug-19-2015
4 Medtronic Perfusion Systems I Nov-01-2010
5 St. Jude Medical Cardiovascular Division II Feb-17-2011
6 Symmetry Medical/SSI II May-07-2013

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