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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, hemodialysis, implanted
Regulation Description Blood access device and accessories.
Product CodeMSD
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - KIT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT 6
CARDIOMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 9
MEDCOMP
  SUBSTANTIALLY EQUIVALENT - KIT 12
  SUBSTANTIALLY EQUIVALENT 14
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 5
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT - KIT 1
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
VASCA INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 293
Crack 198
Fluid leak 124
Hole in material 124
Break 103
Migration of device or device component 55
Device operates differently than expected 55
Fracture 54
Air leak 27
Growth, will not support 23
Material separation 23
Kinked 18
Failure to Adhere or Bond 18
Occlusion within device 17
Device, removal of (non-implant) 17
Detachment of device or device component 17
Detachment of device component 16
Material disintegration 14
Split 14
No Known Device Problem 13
Use of Device Issue 12
Difficult to remove 11
Restricted flowrate 11
Cut in material 10
Material deformation 9
Disconnection 9
Infusion or flow issue 8
No Information 8
Inaccurate flowrate 7
Unknown (for use when the device problem is not known) 7
Unraveled material 6
Component(s), broken 6
Bleed back 6
Torn material 6
Connection issue 6
Unintended movement 5
Bent 5
Decoupling 5
Improper or incorrect procedure or method 5
Material rupture 5
Difficult to insert 5
Contamination during use 4
Material fragmentation 4
Adaptor, failure of 4
Blockage within device or device component 4
Human-Device Interface Issue 4
Implant, removal of 4
Other (for use when an appropriate device code cannot be identified) 4
Device damaged prior to use 3
No code available 3
Coagulation in device or device ingredient 3
Loose or intermittent connection 3
Material puncture 3
Insufficient flow or underinfusion 3
Sticking 3
Device inoperable 2
Tears, rips, holes in device, device material 2
Material perforation 2
Volume accuracy issue 2
Difficult to position 2
Mechanical issue 2
Delivered as unsterile product 2
Collapse 2
Device clogged 2
Material frayed 2
Scratched material 2
Positioning Issue 2
Mechanics altered 2
Obstruction within device 2
Physical resistance 2
Defective item 2
Device or device fragments location unknown 2
Improper flow or infusion 2
Material Distortion 2
Device-device incompatibility 2
Dislodged or dislocated 2
Foreign material present in device 1
Malposition of device 1
Implant breakage or physical damage 1
Patient-device incompatibility 1
Aspiration issue 1
Blocked connection 1
Material integrity issue 1
Material Protrusion 1
Inadequate user interface 1
Failure to disconnect 1
Failure to separate 1
Incorrect or inadequate test results 1
Low readings 1
Structural problem 1
Failure to align 1
Failure to obtain samples 1
Incomplete or missing packaging 1
Failure to infuse 1
Device Issue 1
Malfunction 1
Moisture or humidity problem 1
No flow 1
Packaging issue 1
Pressure issue 1
Total Device Problems 1490

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 2 2 1 2 2 0 2 3 0 0
Class III 0 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Jan-12-2012
2 Angiodynamics, Inc. II Jan-11-2012
3 Angiodynamics, Inc. II Jun-04-2010
4 Angiodynamics, Inc. II Sep-24-2008
5 Argon Medical Devices, Inc II Sep-24-2014
6 Arrow International Inc II Jan-22-2015
7 Arrow International Inc I Jul-30-2011
8 Arrow International Inc II Sep-17-2008
9 Bard Access Systems III Aug-27-2012
10 Covidien LLC II Jul-01-2015
11 Medical Components, Inc dba MedComp II Mar-30-2015
12 Medical Components, Inc dba MedComp II Sep-04-2014
13 Medical Components, Inc dba MedComp II Jun-28-2011
14 Medical Components, Inc dba MedComp II Nov-10-2009
15 R4 Vascular Inc II Jun-06-2011
16 Spire Biomedical, Inc. II Nov-17-2009

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