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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ultrasound, intravascular
Regulation Description Diagnostic intravascular catheter.
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product CodeOBJ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 8
JOMED
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 6
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
Retraction problem 332
No display or display failure 136
Entrapment of device or device component 130
Poor quality image 64
Use of Device Issue 61
Material separation 52
No Known Device Problem 50
Detachment of device component 38
Break 22
Difficult to remove 21
Improper device output 20
Device operates differently than expected 19
Output issue 17
False device output 16
Incorrect or inadequate result 13
Physical resistance 10
Foreign material present in device 9
Device displays error message 8
Kinked 8
Erratic display 7
Fluid leak 6
Fracture 6
Peeled 6
Positioning Issue 6
Torn material 5
No Information 5
Material fragmentation 5
Artifact 5
Detachment of device or device component 5
Difficult to advance 5
Unable to obtain readings 5
Failure to advance 4
Material deformation 3
Device sensing issue 3
Crack 3
Incorrect display 3
Fire 3
Migration of device or device component 3
Difficult to insert 2
Device emits odor 2
Hole in material 2
Leak 2
Loss of or failure to bond 2
Contamination during use 2
Device packaging compromised 2
Overheating of device or device component 2
Device Issue 2
Improper or incorrect procedure or method 2
Invalid sensing 2
Material Protrusion 2
Mechanical jam 1
Component missing 1
Out-of-box failure 1
Tear, rip or hole in device packaging 1
Failure to calibrate 1
Device or device fragments location unknown 1
Smoking 1
Sticking 1
Inaccurate synchronization 1
Unraveled material 1
Device markings issue 1
Malposition of device 1
Ambient noise issue 1
Communication or transmission issue 1
Connection issue 1
Loss of Data 1
Deployment issue 1
Device-device incompatibility 1
Electrical shorting 1
Human-Device Interface Issue 1
Incompatibility problem 1
Material disintegration 1
Bent 1
Circuit Failure 1
Coiled 1
Electrical issue 1
False negative result 1
Loose or intermittent connection 1
Difficult to flush 1
Image resolution poor 1
No device output 1
Difficult to position 1
Material puncture 1
Delivered as unsterile product 1
Occlusion within device 1
Total Device Problems 1173

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 0 0 0 0 0 0 0 0 4 1 2
Class III 0 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-26-2017
2 Arrow International Inc II Aug-31-2015
3 Arrow International Inc III Jan-29-2015
4 Biosense Webster, Inc. II Oct-01-2015
5 VasoNova, Inc. II Apr-09-2015
6 Volcano Corporation II Apr-10-2017
7 Volcano Corporation II May-25-2016
8 Volcano Corporation II Jun-25-2015

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