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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter,intracardiac mapping,high-density array
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeMTD
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SE - WITH LIMITATIONS 3
  SUBSTANTIALLY EQUIVALENT 3
ENDOCARDIAL SOLUTIONS
  SE - WITH LIMITATIONS 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device or device component 15
Difficult to remove 10
Improper or incorrect procedure or method 5
Hole in material 5
Leak 5
Device or device component damaged by another device 4
No Known Device Problem 4
Scratched material 3
Device displays error message 3
Bent 3
Break 3
Electrical issue 2
Electrode(s), migration of 2
Failure to Adhere or Bond 2
Foreign material present in device 2
Device operates differently than expected 1
Noise, Audible 1
Folded 1
Retraction problem 1
Shaft, split 1
Device packaging compromised 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Entrapment of device or device component 1
False reading from device non-compliance 1
Fluid leak 1
Electrode(s), failure of 1
Occlusion within device 1
Burn of device or device component 1
Charred 1
Device clogged 1
Collapse 1
Component(s), broken 1
Detachment of device component 1
Contamination during use 1
Difficult to deploy 1
Incorrect display 1
Total Device Problems 90

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Electrophysiology III Aug-28-2015
2 Biosense Webster, Inc. II Apr-29-2016
3 Biosense Webster, Inc. II Mar-11-2014

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