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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 33
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 195
Fluid leak 153
Break 151
Fracture 74
Material separation 61
Detachment of device or device component 56
Material fragmentation 47
Detachment of device component 42
Migration of device or device component 41
Unraveled material 39
Hole in material 36
Buckled material 36
Split 36
Device, removal of (non-implant) 36
Difficult to remove 35
Material deformation 31
Dislodged or dislocated 28
Occlusion within device 23
Crack 23
Material rupture 22
Physical resistance 21
No Known Device Problem 21
Other (for use when an appropriate device code cannot be identified) 18
Material frayed 17
Kinked 17
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
No Information 7
Device-device incompatibility 7
Deployment issue 7
Torn material 6
Not Applicable 6
Burst 6
Difficult to insert 6
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
Wrinkled 4
Connection issue 3
No code available 3
Pressure issue 3
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
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
Contamination during use 2
Disassembly 2
Collapse 2
Bleed back 2
Infusion or flow issue 2
Cut in material 2
Malposition of device 2
Folded 2
Patient-device incompatibility 1
Foreign material present in device 1
Gas leak 1
Inadequate user interface 1
Material Protrusion 1
Material twisted 1
Mechanical jam 1
Mechanics altered 1
Mushroomed 1
Medication Error 1
Output issue 1
Material Distortion 1
Biofilm coating in device 1
Aspiration, incomplete 1
Disconnection 1
Explanted 1
Foreign material 1
Material invagination 1
Material puncture 1
Therapy delivered to incorrect body area 1
Total Device Problems 1534

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 1
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 Navilyst Medical, Inc., an AngioDyamics Company II Jun-14-2016
20 Pfm Medical Inc II Dec-12-2014
21 Vygon Corporation II Mar-11-2013
22 Vygon Corporation II Jun-29-2011

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