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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter,intravascular,therapeutic,long-term greater than 30 days
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 10
ARROW INTL., INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
  SUBSTANTIALLY EQUIVALENT 12
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BD
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 32
COOK, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
FLEXICATH LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 4
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERRAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
KLEIN-BAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LUCENT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 11
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 15
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Leak 193
Break 151
Fluid leak 147
Fracture 61
Material separation 57
Detachment of device or device component 55
Material fragmentation 43
Detachment of device component 42
Migration of device or device component 41
Unraveled material 39
Hole in material 36
Device, removal of (non-implant) 36
Split 35
Difficult to remove 35
Material deformation 31
Dislodged or dislocated 28
Buckled material 24
Crack 23
Material rupture 22
Physical resistance 21
Occlusion within device 20
Other (for use when an appropriate device code cannot be identified) 18
Material frayed 17
No Known Device Problem 17
Kinked 16
Component(s), broken 13
Failure to separate 12
Device operates differently than expected 12
Knotted 11
Stretched 10
Blockage within device or device component 9
Defective item 9
Material integrity issue 9
Difficult to advance 8
Failure to advance 8
Human-Device Interface Issue 7
Device-device incompatibility 7
Deployment issue 7
Torn material 6
Not Applicable 6
No Information 6
Difficult to insert 6
Burst 5
Uncoiled 5
Use of Device Issue 4
Device, or device fragments remain in patient 4
Air leak 4
Bent 4
Decoupling 4
Entrapment of device or device component 4
Difficult to flush 3
Loose or intermittent connection 3
Tears, rips, holes in device, device material 3
Sticking 3
Twisting 3
Unknown (for use when the device problem is not known) 3
Material perforation 3
Wire(s), breakage of 3
No code available 3
Connection issue 3
Wrinkled 3
Pressure issue 3
Malposition of device 2
Cut in material 2
Infusion or flow issue 2
Defective component 2
Component missing 2
Fitting problem 2
Tip breakage 2
Slippage of device or device component 2
Improper or incorrect procedure or method 2
Decrease in pressure 2
Failure to flush 2
Material erosion 2
Component falling 2
Disassembly 2
Collapse 2
Bleed back 2
Biofilm coating in device 1
Aspiration, incomplete 1
Disconnection 1
Contamination during use 1
Explanted 1
Foreign material 1
Material invagination 1
Material puncture 1
Therapy delivered to incorrect body area 1
Reflux within device 1
Rejection 1
Insufficient flow or underinfusion 1
Percutaneous 1
Retraction problem 1
Shaft break 1
Device damaged prior to use 1
Out-of-box failure 1
Device contamination with blood or blood product 1
Implant, removal of 1
Failure to infuse 1
Device Issue 1
Obstruction within device 1
Total Device Problems 1478

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 0 1 1 1 3 2 2 3 5 0
Class III 0 0 0 0 0 1 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Feb-21-2012
2 Angiodynamics Worldwide Headquarters II Jan-26-2012
3 Angiodynamics Worldwide Headquarters III Jan-11-2012
4 Arrow International Inc II Nov-04-2015
5 Arrow International Inc II Oct-15-2015
6 Arrow International Inc II Aug-25-2015
7 Arrow International Inc II Apr-24-2014
8 Arrow International Inc II May-26-2010
9 Arrow International Inc II Jun-24-2009
10 Bard Access Systems II Sep-23-2015
11 Bard Access Systems III Jul-08-2015
12 Bard Access Systems II Mar-13-2015
13 Bard Access Systems II Jul-11-2011
14 Bard Access Systems II Jan-06-2011
15 Cook, Inc. I Feb-23-2011
16 Medical Components, Inc dba MedComp II Feb-28-2013
17 Medical Components, Inc dba MedComp II Sep-16-2008
18 Navilyst Medical, Inc II Oct-07-2014
19 Pfm Medical Inc II Dec-12-2014
20 Vygon Corporation II Mar-11-2013
21 Vygon Corporation II Jun-29-2011

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