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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, irrigation
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBX
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN CATHETER
  SUBSTANTIALLY EQUIVALENT 1
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 3
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DMC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
TAUT
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 101
Fluid leak 11
Material separation 11
Occlusion within device 10
Fracture 7
Difficult to insert 7
Tear, rip or hole in device packaging 5
Migration of device or device component 4
Detachment of device component 4
Detachment of device or device component 4
Material twisted 3
Torn material 3
Disconnection 3
Kinked 3
Device, or device fragments remain in patient 3
Difficult to remove 3
Difficult to position 2
Degraded 2
Delivered as unsterile product 2
Tip breakage 2
Device damaged prior to use 2
Restricted flowrate 2
Misassembled 2
Misplacement 1
Leak 1
Loose or intermittent connection 1
Component falling 1
Crack 1
Burst 1
Material fragmentation 1
Hole in material 1
Wire(s), breakage of 1
Suction issue 1
Split 1
Defective item 1
Device, removal of (non-implant) 1
Aspiration issue 1
Unsealed device packaging 1
Product quality issue 1
No Information 1
No code available 1
No Known Device Problem 1
Device markings issue 1
Device operates differently than expected 1
Difficult to advance 1
Dislodged or dislocated 1
Foreign material present in device 1
Inadequate user interface 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Total Device Problems 223

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

Recalls
Manufacturer Recall Class Date Posted
1 Hospira Inc. II May-16-2014
2 Linvatec Corp. dba ConMed Linvatec II Sep-27-2012
3 Merit Medical Systems, Inc. II Jan-07-2011

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