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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 34
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 238
Fluid leak 194
Break 164
Fracture 126
Buckled material 94
Material separation 83
Detachment of device or device component 60
Material fragmentation 54
Detachment of device component 45
Split 45
Crack 44
Migration of device or device component 43
Unraveled material 43
Hole in material 38
Difficult to remove 37
Device, removal of (non-implant) 36
Occlusion within device 32
Material deformation 31
No Known Device Problem 31
Kinked 30
Dislodged or dislocated 28
Physical resistance 28
Material rupture 27
Other (for use when an appropriate device code cannot be identified) 18
Material frayed 18
Failure to separate 14
Device operates differently than expected 13
Knotted 13
Component(s), broken 13
Stretched 10
Blockage within device or device component 10
Material integrity issue 9
Defective item 9
Failure to advance 8
Difficult to advance 8
No Information 8
Uncoiled 8
Burst 7
Torn material 7
Deployment issue 7
Device-device incompatibility 7
Human-Device Interface Issue 7
Connection issue 6
Not Applicable 6
Bleed back 6
Difficult to insert 6
Difficult to flush 5
Air leak 4
Bent 4
Decoupling 4
Entrapment of device or device component 4
Use of Device Issue 4
Device, or device fragments remain in patient 4
Infusion or flow issue 4
Wrinkled 4
Cut in material 3
Wire(s), breakage of 3
Pressure issue 3
No code available 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
Component missing 3
Loose or intermittent connection 3
Failure to flush 2
Component falling 2
Contamination during use 2
Material erosion 2
Disassembly 2
Collapse 2
Fitting problem 2
Improper or incorrect procedure or method 2
Tip breakage 2
Slippage of device or device component 2
Decrease in pressure 2
Defective component 2
Obstruction within device 2
Aspiration issue 2
Malposition of device 2
Folded 2
Patient-device incompatibility 1
Device Issue 1
Failure to obtain samples 1
Foreign material present in device 1
Gas leak 1
Inadequate user interface 1
Material Distortion 1
Material Protrusion 1
Material twisted 1
Mechanical jam 1
Mechanics altered 1
Mushroomed 1
Medication Error 1
Output issue 1
Material puncture 1
Therapy delivered to incorrect body area 1
Reflux within device 1
Rejection 1
Total Device Problems 1889

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 0
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 Sep-09-2016
7 Arrow International Inc II Nov-04-2015
8 Arrow International Inc II Oct-15-2015
9 Arrow International Inc II Aug-25-2015
10 Arrow International Inc II Apr-24-2014
11 Arrow International Inc II May-26-2010
12 Arrow International Inc II Jun-24-2009
13 Bard Access Systems II Sep-23-2015
14 Bard Access Systems III Jul-08-2015
15 Bard Access Systems II Mar-13-2015
16 Bard Access Systems II Jul-11-2011
17 Bard Access Systems II Jan-06-2011
18 Cook, Inc. I Feb-23-2011
19 Medical Components, Inc dba MedComp II Feb-28-2013
20 Medical Components, Inc dba MedComp II Sep-16-2008
21 Navilyst Medical, Inc II Oct-07-2014
22 Navilyst Medical, Inc., an AngioDyamics Company II Jun-14-2016
23 Pfm Medical Inc II Dec-12-2014
24 Vygon Corporation II Mar-11-2013
25 Vygon Corporation II Jun-29-2011

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