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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 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
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 13
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 187
No Known Device Problem 117
Physical resistance 95
Obstruction within device 93
Detachment of device component 72
Burst 58
Material separation 57
Balloon leak(s) 56
Fracture 53
Aspiration issue 48
Leak 47
Material rupture 40
No code available 37
Device displays error message 36
Device damaged prior to use 36
Unknown (for use when the device problem is not known) 35
Inflation issue 34
Balloon burst 32
Difficult to remove 30
Hole in material 29
Other (for use when an appropriate device code cannot be identified) 28
Detachment of device or device component 28
Entrapment of device or device component 24
Deflation issue 20
Dislodged or dislocated 19
Material integrity issue 19
Mechanical issue 19
Peeled 19
Difficult to advance 16
Occlusion within device 16
Interference 15
Kinked 15
Foreign material present in device 14
Material fragmentation 13
Crack 13
Device or device component damaged by another device 12
Difficult to insert 11
Incorrect measurement 11
Device operates differently than expected 10
Failure to advance 10
Buckled material 9
Delamination 8
Tip breakage 7
Flaked 7
Device or device fragments location unknown 6
Stretched 6
Torn material 6
Device, or device fragments remain in patient 6
Device inoperable 5
Balloon rupture 5
Device markings issue 5
Shaft break 5
Blockage within device or device component 4
Sticking 4
Disconnection 4
No Information 4
Material perforation 4
Fluid leak 4
Use of Device Issue 4
Component missing 4
No flow 3
Unraveled material 3
Tube(s), defective 3
Foreign material 3
Premature deployment 3
Split 3
Improper flow or infusion 3
Deflation, cause unknown 3
Positioning Issue 3
Measurements, inaccurate 3
Restricted flowrate 3
Fitting problem 3
Resistance, inadequate 3
Unsealed device packaging 3
Device clogged 3
Device handling issue 3
Failure to deploy 3
Wire(s), breakage of 3
Air leak 2
Device remains implanted 2
Device Issue 2
Loose or intermittent connection 2
Difficult to position 2
Component(s), broken 2
Migration of device or device component 2
Device stops intermittently 2
Material frayed 2
Material puncture 2
Difficult to flush 2
Deployment issue 1
Loss of or failure to bond 1
Retraction problem 1
Failure to deliver 1
Biofilm coating in device 1
Shaft, split 1
Connection issue 1
Output above specifications 1
Disinfection or Sterilization Issue at User Location 1
Misassembled 1
Low readings 1
Total Device Problems 1718

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 0
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 Nov-06-2015
11 Cordis Corporation II Dec-30-2008
12 Covidien I Feb-03-2015
13 EKOS Corporation II Sep-21-2016
14 EKOS Corporation II Feb-24-2016
15 EKOS Corporation II Jul-20-2015
16 EKOS Corporation II Nov-01-2013
17 EKOS Corporation II Jul-17-2012
18 EKOS Corporation II Sep-16-2008
19 EKOS Corporation II Sep-02-2008
20 EKOS Corporation II Aug-20-2008
21 Edwards Lifesciences AG II Aug-25-2009
22 Edwards Lifesciences, LLC II Apr-18-2013
23 Edwards Lifesciences, Llc II Apr-17-2009
24 Ekos Corp II Mar-08-2007
25 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
26 Merit Medical Systems, Inc. II Oct-31-2014
27 Merit Medical Systems, Inc. II Dec-31-2013
28 Merit Medical Systems, Inc. II Mar-02-2010
29 Merit Medical Systems, Inc. II Sep-11-2008
30 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
31 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-27-2012
32 Sequent Medical Inc II Oct-27-2016

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