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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 132
No Known Device Problem 100
Physical resistance 75
Obstruction within device 70
Detachment of device component 65
Balloon leak(s) 56
Burst 51
Material separation 48
Leak 46
Material rupture 39
No code available 36
Unknown (for use when the device problem is not known) 35
Inflation issue 34
Fracture 33
Balloon burst 32
Other (for use when an appropriate device code cannot be identified) 28
Hole in material 26
Device damaged prior to use 25
Detachment of device or device component 24
Difficult to remove 24
Entrapment of device or device component 21
Deflation issue 20
Mechanical issue 19
Material integrity issue 18
Peeled 17
Occlusion within device 16
Interference 15
Difficult to advance 15
Aspiration issue 13
Dislodged or dislocated 12
Foreign material present in device 12
Kinked 11
Material fragmentation 11
Crack 11
Incorrect measurement 11
Difficult to insert 10
Device operates differently than expected 9
Failure to advance 9
Tip breakage 7
Device, or device fragments remain in patient 6
Device or device component damaged by another device 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
No Information 4
Positioning Issue 3
No flow 3
Fitting problem 3
Material perforation 3
Tube(s), defective 3
Wire(s), breakage of 3
Improper flow or infusion 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
Split 2
Device Issue 2
Device handling issue 2
Output issue 1
Packaging issue 1
Cut in material 1
Low readings 1
Device, removal of (non-implant) 1
Failure to deliver 1
Inaccurate delivery 1
Blocked connection 1
Buckled material 1
Connection issue 1
Delamination 1
Delivery system failure 1
Deployment issue 1
Incompatibility problem 1
Device packaging compromised 1
Total Device Problems 1406

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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