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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 11
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 6
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 154
No Known Device Problem 109
Physical resistance 80
Obstruction within device 79
Detachment of device component 67
Balloon leak(s) 56
Burst 54
Material separation 52
Leak 46
Material rupture 39
Fracture 39
No code available 36
Unknown (for use when the device problem is not known) 35
Inflation issue 34
Balloon burst 32
Device damaged prior to use 32
Other (for use when an appropriate device code cannot be identified) 28
Hole in material 27
Difficult to remove 25
Detachment of device or device component 24
Entrapment of device or device component 22
Deflation issue 20
Mechanical issue 19
Material integrity issue 19
Aspiration issue 18
Peeled 17
Occlusion within device 16
Difficult to advance 16
Interference 15
Dislodged or dislocated 14
Foreign material present in device 12
Kinked 12
Material fragmentation 12
Crack 12
Difficult to insert 11
Incorrect measurement 11
Failure to advance 10
Device operates differently than expected 9
Device displays error message 9
Device or device component damaged by another device 8
Tip breakage 7
Device, or device fragments remain in patient 6
Torn material 6
Device markings issue 5
Device or device fragments location unknown 5
Device inoperable 5
Stretched 5
Shaft break 5
Balloon rupture 5
Blockage within device or device component 4
Disconnection 4
Fluid leak 4
Sticking 4
Component missing 4
Use of Device Issue 4
No Information 4
Device handling issue 3
No flow 3
Improper flow or infusion 3
Positioning Issue 3
Fitting problem 3
Material perforation 3
Tube(s), defective 3
Wire(s), breakage of 3
Unraveled material 3
Resistance, inadequate 3
Premature deployment 3
Unsealed device packaging 3
Failure to deploy 3
Restricted flowrate 3
Foreign material 3
Measurements, inaccurate 3
Deflation, cause unknown 3
Device clogged 3
Component(s), broken 2
Air leak 2
Material frayed 2
Difficult to flush 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
Split 2
Buckled material 2
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Delamination 1
Delivery system failure 1
Deployment issue 1
Device, removal of (non-implant) 1
Blocked connection 1
Device packaging compromised 1
Free or unrestricted flow 1
Cut in material 1
Low readings 1
Failure to deliver 1
Inaccurate delivery 1
Output issue 1
Total Device Problems 1499

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 1 0
Class II 1 5 3 4 1 4 3 2 3 1
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 Feb-24-2016
14 EKOS Corporation II Jul-20-2015
15 EKOS Corporation II Nov-01-2013
16 EKOS Corporation II Jul-17-2012
17 EKOS Corporation II Sep-16-2008
18 EKOS Corporation II Sep-02-2008
19 EKOS Corporation II Aug-20-2008
20 Edwards Lifesciences AG II Aug-25-2009
21 Edwards Lifesciences, LLC II Apr-18-2013
22 Edwards Lifesciences, Llc II Apr-17-2009
23 Ekos Corp II Mar-08-2007
24 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
25 Merit Medical Systems, Inc. II Oct-31-2014
26 Merit Medical Systems, Inc. II Dec-31-2013
27 Merit Medical Systems, Inc. II Mar-02-2010
28 Merit Medical Systems, Inc. II Sep-11-2008
29 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-27-2012

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