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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, continuous flush
Regulation Description Continuous flush catheter.
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
BACCHUS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 7
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 14
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 15
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EKOS CORP.
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 17
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOWMEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 3
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 17
SCIMED
  SUBSTANTIALLY EQUIVALENT 6
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
VASCON LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR DESIGNS INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 233
No Known Device Problem 134
Physical resistance 114
Obstruction within device 100
Aspiration issue 82
Detachment of device component 78
Device displays error message 69
Material separation 66
Burst 62
Fracture 58
Leak 58
Balloon leak(s) 56
Difficult to remove 54
Material rupture 43
Device damaged prior to use 39
No code available 37
Unknown (for use when the device problem is not known) 35
Inflation issue 34
Entrapment of device or device component 32
Balloon burst 32
Detachment of device or device component 31
Hole in material 30
Other (for use when an appropriate device code cannot be identified) 28
Dislodged or dislocated 25
Material integrity issue 24
Deflation issue 20
Peeled 20
Mechanical issue 19
Kinked 18
Occlusion within device 17
Difficult to advance 17
Device or device component damaged by another device 15
Interference 15
Foreign material present in device 14
Difficult to insert 13
Material fragmentation 13
Crack 13
Incorrect measurement 11
Device operates differently than expected 11
Device inoperable 10
Failure to advance 10
Buckled material 9
Delamination 8
Fluid leak 8
Flaked 7
Stretched 7
Tip breakage 7
Device, or device fragments remain in patient 6
Device or device fragments location unknown 6
Torn material 6
Device markings issue 5
Shaft break 5
Balloon rupture 5
Blockage within device or device component 4
Failure to deploy 4
Disconnection 4
Sticking 4
Component missing 4
Use of Device Issue 4
Material perforation 4
No Information 4
Positioning Issue 4
Device handling issue 4
Improper flow or infusion 3
No flow 3
Tube(s), defective 3
Fitting problem 3
Unraveled material 3
Wire(s), breakage of 3
Split 3
Resistance, inadequate 3
Unsealed device packaging 3
Premature deployment 3
Restricted flowrate 3
Foreign material 3
Measurements, inaccurate 3
Deflation, cause unknown 3
Device clogged 3
Component(s), broken 2
Air leak 2
Difficult to flush 2
Material frayed 2
Material puncture 2
Difficult to position 2
Device remains implanted 2
Loose or intermittent connection 2
Migration of device or device component 2
Incorrect or inadequate result 2
Device stops intermittently 2
Device Issue 2
Failure to deliver 1
Inaccurate delivery 1
Cut in material 1
Low readings 1
Delivery system failure 1
Deployment issue 1
Device packaging compromised 1
Device, removal of (non-implant) 1
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Total Device Problems 1988

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

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Feb-28-2012
2 Angiodynamics Worldwide Headquarters II Jan-11-2012
3 Angiodynamics Worldwide Headquarters II Sep-19-2011
4 Angiodynamics, Inc. II Aug-18-2014
5 Angiodynamics, Inc. II May-28-2010
6 Angiodynamics, Inc. II May-27-2010
7 Boston Scientific Corporation II Nov-15-2010
8 Boston Scientific Corporation II Sep-24-2009
9 Boston Scientific Corporation III Oct-31-2007
10 Cook Inc. II Mar-02-2017
11 Cook Inc. II Nov-06-2015
12 Cordis Corporation II Dec-30-2008
13 Covidien I Feb-03-2015
14 EKOS Corporation II Sep-21-2016
15 EKOS Corporation II Feb-24-2016
16 EKOS Corporation II Jul-20-2015
17 EKOS Corporation II Nov-01-2013
18 EKOS Corporation II Jul-17-2012
19 EKOS Corporation II Sep-16-2008
20 EKOS Corporation II Sep-02-2008
21 EKOS Corporation II Aug-20-2008
22 Edwards Lifesciences AG II Aug-25-2009
23 Edwards Lifesciences, LLC II Apr-18-2013
24 Edwards Lifesciences, Llc II Apr-17-2009
25 Ekos Corp II Mar-08-2007
26 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
27 Merit Medical Systems, Inc. II Oct-31-2014
28 Merit Medical Systems, Inc. II Dec-31-2013
29 Merit Medical Systems, Inc. II Mar-02-2010
30 Merit Medical Systems, Inc. II Sep-11-2008
31 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
32 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-27-2012
33 Sequent Medical Inc II Oct-27-2016

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