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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 10
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 2
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 125
No Known Device Problem 93
Obstruction within device 69
Physical resistance 67
Detachment of device component 60
Balloon leak(s) 56
Burst 48
Material separation 45
Leak 44
Material rupture 39
No code available 36
Unknown (for use when the device problem is not known) 35
Inflation issue 34
Balloon burst 32
Other (for use when an appropriate device code cannot be identified) 28
Fracture 27
Hole in material 26
Difficult to remove 24
Device damaged prior to use 24
Detachment of device or device component 24
Entrapment of device or device component 21
Deflation issue 20
Mechanical issue 19
Material integrity issue 17
Interference 15
Occlusion within device 14
Peeled 13
Difficult to advance 13
Foreign material present in device 12
Incorrect measurement 11
Material fragmentation 11
Crack 11
Kinked 10
Difficult to insert 10
Device operates differently than expected 9
Failure to advance 9
Aspiration issue 8
Dislodged or dislocated 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
Device displays error message 4
Component missing 4
Use of Device Issue 4
Device or device component damaged by another device 4
Improper flow or infusion 3
Fitting problem 3
Material perforation 3
Tube(s), defective 3
Wire(s), breakage of 3
Positioning Issue 3
No flow 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
No Information 2
Device handling issue 2
Split 2
Blocked connection 1
Buckled material 1
Connection issue 1
Delamination 1
Delivery system failure 1
Deployment issue 1
Incompatibility problem 1
Free or unrestricted flow 1
Device Issue 1
Cut in material 1
Low readings 1
Device, removal of (non-implant) 1
Inaccurate delivery 1
Output issue 1
Packaging issue 1
Misassembled 1
Output above specifications 1
Total Device Problems 1338

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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