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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 35
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 256
Fluid leak 217
Break 184
Fracture 132
Buckled material 95
Material separation 94
Detachment of device or device component 65
Material fragmentation 56
Split 52
Crack 51
Detachment of device component 47
Unraveled material 46
Migration of device or device component 43
Hole in material 43
Difficult to remove 42
Occlusion within device 42
Device, removal of (non-implant) 36
No Known Device Problem 35
Material deformation 34
Kinked 31
Physical resistance 29
Dislodged or dislocated 29
Material rupture 28
Material frayed 20
Other (for use when an appropriate device code cannot be identified) 18
Device operates differently than expected 14
Failure to separate 14
Component(s), broken 13
Knotted 13
Blockage within device or device component 13
Stretched 10
Material integrity issue 10
Defective item 9
Failure to advance 9
Difficult to advance 8
Torn material 8
No Information 8
Uncoiled 8
Burst 7
Bent 7
Device-device incompatibility 7
Connection issue 7
Deployment issue 7
Human-Device Interface Issue 7
Device Issue 7
Not Applicable 6
Bleed back 6
Difficult to insert 6
Difficult to flush 6
Air leak 4
Decoupling 4
Entrapment of device or device component 4
Use of Device Issue 4
Material puncture 4
Device, or device fragments remain in patient 4
Infusion or flow issue 4
Defective component 4
Wrinkled 4
Malposition of device 4
Fitting problem 3
Wire(s), breakage of 3
Cut in material 3
Aspiration issue 3
Pressure issue 3
No code available 3
Sticking 3
Twisting 3
Tears, rips, holes in device, device material 3
Unknown (for use when the device problem is not known) 3
Material perforation 3
Component missing 3
Loose or intermittent connection 3
Failure to flush 2
Component falling 2
Contamination during use 2
Material erosion 2
Disassembly 2
Tip breakage 2
Improper or incorrect procedure or method 2
Slippage of device or device component 2
Decrease in pressure 2
Obstruction within device 2
Failure to infuse 2
Folded 2
Patient-device incompatibility 1
Failure to obtain samples 1
Bacterial contamination of device 1
Inadequate user interface 1
Foreign material present in device 1
Gas leak 1
Material Protrusion 1
Material twisted 1
Mechanical jam 1
Mechanics altered 1
Mushroomed 1
Medication Error 1
Material Distortion 1
Output issue 1
Positioning Issue 1
Percutaneous 1
Total Device Problems 2054

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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