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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 9
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 288
No Known Device Problem 150
Physical resistance 136
Obstruction within device 101
Detachment of device component 88
Aspiration issue 82
Material separation 78
Burst 70
Device displays error message 70
Fracture 66
Difficult to remove 64
Leak 63
Balloon leak(s) 56
Material rupture 44
Device damaged prior to use 44
No code available 37
Unknown (for use when the device problem is not known) 35
Detachment of device or device component 35
Inflation issue 34
Entrapment of device or device component 32
Balloon burst 32
Hole in material 31
Dislodged or dislocated 30
Kinked 29
Other (for use when an appropriate device code cannot be identified) 28
Material integrity issue 24
Peeled 21
Deflation issue 20
Mechanical issue 19
Device or device component damaged by another device 19
Difficult to advance 18
Occlusion within device 18
Foreign material present in device 16
Interference 15
Difficult to insert 14
Material fragmentation 14
Crack 14
Device inoperable 13
Failure to advance 12
Device operates differently than expected 12
Incorrect measurement 11
Fluid leak 10
Device handling issue 10
Buckled material 9
Delamination 8
Tip breakage 7
Flaked 7
Stretched 7
Device, or device fragments remain in patient 6
Device or device fragments location unknown 6
Torn material 6
Positioning Issue 5
Device markings issue 5
Shaft break 5
Material puncture 5
Disconnection 5
Balloon rupture 5
Bent 4
Blockage within device or device component 4
Failure to deploy 4
Sticking 4
Use of Device Issue 4
Material perforation 4
Component missing 4
Material deformation 4
No Information 4
No flow 3
Improper flow or infusion 3
Wire(s), breakage of 3
Device Issue 3
Tube(s), defective 3
Fitting problem 3
Unraveled material 3
Split 3
Resistance, inadequate 3
Premature deployment 3
Unsealed device packaging 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
Failure to prime 2
Loose or intermittent connection 2
Migration of device or device component 2
Incorrect or inadequate result 2
Difficult to position 2
Device remains implanted 2
Device stops intermittently 2
Connection issue 2
Device packaging compromised 1
Incompatibility problem 1
Free or unrestricted flow 1
Output issue 1
Packaging issue 1
Material twisted 1
Total Device Problems 2203

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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