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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
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 173
No Known Device Problem 112
Physical resistance 88
Obstruction within device 85
Detachment of device component 69
Burst 57
Balloon leak(s) 56
Material separation 54
Fracture 51
Leak 46
Material rupture 40
Device damaged prior to use 36
No code available 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 28
Other (for use when an appropriate device code cannot be identified) 28
Detachment of device or device component 28
Aspiration issue 24
Entrapment of device or device component 23
Deflation issue 20
Mechanical issue 19
Material integrity issue 19
Dislodged or dislocated 18
Peeled 18
Occlusion within device 16
Difficult to advance 16
Interference 15
Kinked 14
Material fragmentation 13
Crack 13
Foreign material present in device 13
Device displays error message 12
Difficult to insert 11
Incorrect measurement 11
Failure to advance 10
Buckled material 9
Device operates differently than expected 9
Device or device component damaged by another device 8
Delamination 8
Tip breakage 7
Flaked 7
Stretched 6
Device or device fragments location unknown 6
Device, or device fragments remain in patient 6
Torn material 6
Device markings issue 5
Device inoperable 5
Shaft break 5
Balloon rupture 5
Blockage within device or device component 4
Disconnection 4
Fluid leak 4
Sticking 4
Use of Device Issue 4
Component missing 4
No Information 4
Device handling issue 3
Positioning Issue 3
No flow 3
Improper flow or infusion 3
Wire(s), breakage of 3
Split 3
Fitting problem 3
Material perforation 3
Tube(s), defective 3
Unraveled material 3
Resistance, inadequate 3
Unsealed device packaging 3
Premature deployment 3
Foreign material 3
Failure to deploy 3
Restricted flowrate 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
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
Free or unrestricted flow 1
Device, removal of (non-implant) 1
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Total Device Problems 1613

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