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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, flow directed
Regulation Description Flow-directed catheter.
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K801865  CORDIS FLOW DIRECTED BALLOON CATHETER
  2.  K802338  TORQUE CONTROL BALLOON CATHETER
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to pace or properly pace 138
Inflation issue 121
Measurements, inaccurate 107
Balloon leak(s) 89
Deflation issue 78
Material rupture 61
Fluid leak 53
Incorrect or inadequate result 48
Incorrect measurement 35
Other (for use when an appropriate device code cannot be identified) 35
Balloon rupture 33
Break 31
Leak 27
No code available 24
Unable to obtain readings 21
Air leak 20
Detachment of device component 19
Contamination during use 19
No Known Device Problem 16
Unknown (for use when the device problem is not known) 15
Low readings 15
Burst 15
Incorrect display 12
Balloon burst 11
Difficult to remove 11
Component missing 9
Source, detachment from 8
High Readings 8
Device operates differently than expected 8
Difficult to insert 7
Interlumen communication 6
Hole in material 6
Kinked 5
Foreign material present in device 5
Cut in material 5
Failure to sterilize 4
Gas leak 4
Difficult to position 4
Deflation due to damage from surgical instrument 4
Crack 4
Deflation, cause unknown 3
No display or display failure 3
Difficult to flush 3
Foreign material 3
False reading from device non-compliance 3
Component(s), broken 3
Bleed back 3
Balloon asymmetrical 3
Unsealed device packaging 3
Material fragmentation 3
Occlusion within device 3
No device output 3
Detachment of device or device component 3
Material perforation 3
Blood in tubing 3
Defective component 3
Device Issue 2
Pressure, insufficient 2
Electrical wires, defective 2
Device damaged prior to use 2
Unstable 2
Use of Device Issue 2
Wedge, difficult to 2
Wavelength, incorrect 2
Sterility 2
Tip breakage 2
Tubing, incorrect placement of 2
Defective item 2
Material integrity issue 2
Output issue 2
Positioning Issue 2
Misassembled 2
Material frayed 2
Knotted 2
Looping 2
Plugged 2
Material puncture 2
Rupture, cause unknown 2
Failure to sense 2
Material separation 2
Failure to read input signal 2
Entrapment of device or device component 2
Error or warning message, failure to produce 1
Filter leak(s) 1
Inaccurate flowrate 1
Fracture 1
Failure to flush 1
Drift 1
Bent 1
Changes in ambient temperature in device environment 1
Aspiration, excessive 1
Blockage within device or device component 1
Burn of device or device component 1
Coiled 1
Rupture, fold or crease due to 1
Premature deployment 1
Particulates 1
Pacing inadequately 1
Loose 1
Markings unclear 1
Total Device Problems 1259

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 2 0 1 0 0 1 1 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Apr-04-2013
2 B. Braun Medical, Inc. II Jul-23-2007
3 Edwards Lifesciences Technology SARL II Jan-05-2007
4 Edwards Lifesciences, LLC II Jun-02-2015
5 Edwards Lifesciences, LLC II Aug-12-2012
6 Edwards Lifesciences, Llc II Apr-17-2009

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