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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 36
COOK, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 7
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 22
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  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 284
Fluid leak 234
Break 220
Fracture 144
Material separation 98
Buckled material 95
Detachment of device or device component 70
Split 64
Crack 62
Material fragmentation 60
Occlusion within device 54
Unraveled material 51
Detachment of device component 47
Migration of device or device component 46
Hole in material 45
Difficult to remove 43
No Known Device Problem 40
Device, removal of (non-implant) 36
Material deformation 35
Kinked 34
Material rupture 30
Dislodged or dislocated 29
Physical resistance 29
Material frayed 20
Other (for use when an appropriate device code cannot be identified) 18
Knotted 16
Blockage within device or device component 15
Device operates differently than expected 15
Failure to separate 14
Stretched 13
Component(s), broken 13
Difficult to advance 10
Material integrity issue 10
Defective item 9
Failure to advance 9
Uncoiled 9
Difficult to flush 9
Bent 8
Deployment issue 8
Torn material 8
No Information 8
Device-device incompatibility 7
Human-Device Interface Issue 7
Connection issue 7
Device Issue 7
Burst 7
Bleed back 6
Difficult to insert 6
Not Applicable 6
Cut in material 5
Malposition of device 5
Use of Device Issue 5
Material puncture 5
Device, or device fragments remain in patient 4
Sticking 4
Entrapment of device or device component 4
Air leak 4
Decoupling 4
Wrinkled 4
Defective component 4
Infusion or flow issue 4
No code available 3
Pressure issue 3
Wire(s), breakage of 3
Component missing 3
Aspiration issue 3
Loose or intermittent connection 3
Twisting 3
Tears, rips, holes in device, device material 3
Fitting problem 3
Unknown (for use when the device problem is not known) 3
Material perforation 3
Device damaged prior to use 3
Improper or incorrect procedure or method 2
Tip breakage 2
Slippage of device or device component 2
Decrease in pressure 2
Material erosion 2
Failure to flush 2
Component falling 2
Contamination during use 2
Disassembly 2
Material disintegration 2
Folded 2
Failure to infuse 2
Obstruction within device 2
Mushroomed 2
Material twisted 2
Mechanical jam 1
Mechanics altered 1
Material Protrusion 1
Material Distortion 1
Medication Error 1
Output issue 1
Positioning Issue 1
Failure to obtain samples 1
Bacterial contamination of device 1
Out-of-box failure 1
Device contamination with blood or blood product 1
Implant, removal of 1
Total Device Problems 2245

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 0 0 0 0 0
Class II 0 1 1 1 3 2 2 3 5 4 4
Class III 0 0 0 0 0 1 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-07-2016
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-05-2016
3 Angiodynamics Worldwide Headquarters II Feb-21-2012
4 Angiodynamics Worldwide Headquarters II Jan-26-2012
5 Angiodynamics Worldwide Headquarters III Jan-11-2012
6 Arrow International Inc II Jun-27-2017
7 Arrow International Inc II Jun-12-2017
8 Arrow International Inc II Mar-08-2017
9 Arrow International Inc II Feb-22-2017
10 Arrow International Inc II Sep-09-2016
11 Arrow International Inc II Nov-04-2015
12 Arrow International Inc II Oct-15-2015
13 Arrow International Inc II Aug-25-2015
14 Arrow International Inc II Apr-24-2014
15 Arrow International Inc II May-26-2010
16 Arrow International Inc II Jun-24-2009
17 Bard Access Systems II Sep-23-2015
18 Bard Access Systems III Jul-08-2015
19 Bard Access Systems II Mar-13-2015
20 Bard Access Systems II Jul-11-2011
21 Bard Access Systems II Jan-06-2011
22 Cook, Inc. I Feb-23-2011
23 Medical Components, Inc dba MedComp II Feb-28-2013
24 Medical Components, Inc dba MedComp II Sep-16-2008
25 Navilyst Medical, Inc II Oct-07-2014
26 Navilyst Medical, Inc., an AngioDyamics Company II Jun-14-2016
27 Pfm Medical Inc II Dec-12-2014
28 Vygon Corporation II Mar-11-2013
29 Vygon Corporation II Jun-29-2011

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