• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 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 228
Fluid leak 182
Break 157
Fracture 120
Buckled material 84
Material separation 77
Detachment of device or device component 58
Material fragmentation 53
Detachment of device component 45
Split 43
Migration of device or device component 42
Crack 42
Unraveled material 41
Hole in material 37
Difficult to remove 36
Device, removal of (non-implant) 36
Material deformation 31
No Known Device Problem 30
Occlusion within device 30
Kinked 29
Dislodged or dislocated 28
Physical resistance 26
Material rupture 25
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
Component(s), broken 13
Knotted 12
Stretched 10
Blockage within device or device component 9
Material integrity issue 9
Defective item 9
Failure to advance 8
Difficult to advance 8
Device-device incompatibility 7
Deployment issue 7
Human-Device Interface Issue 7
Torn material 7
No Information 7
Burst 7
Uncoiled 7
Difficult to insert 6
Not Applicable 6
Bleed back 5
Air leak 4
Bent 4
Decoupling 4
Entrapment of device or device component 4
Difficult to flush 4
Use of Device Issue 4
Device, or device fragments remain in patient 4
Connection issue 4
Wrinkled 4
Wire(s), breakage of 3
Cut in material 3
No code available 3
Pressure issue 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
Malposition of device 2
Folded 2
Aspiration issue 2
Infusion or flow issue 2
Material Distortion 1
Material Protrusion 1
Material twisted 1
Mechanical jam 1
Mechanics altered 1
Mushroomed 1
Inadequate user interface 1
Foreign material present in device 1
Gas leak 1
Patient-device incompatibility 1
Device Issue 1
Obstruction within device 1
Failure to obtain samples 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 1807

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

-
-