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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bronchoscope accessory
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Product CodeKTI
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASTHMATX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burst 9
Detachment of device component 8
Other (for use when an appropriate device code cannot be identified) 8
Material separation 4
Deflation issue 4
Balloon rupture 2
Foreign material 2
Fracture 2
Material fragmentation 2
Leak 2
Balloon leak(s) 2
Break 2
Source, detachment from 1
Cut in material 1
No Information 1
Difficult to insert 1
Device markings issue 1
Normal 1
Peeled 1
Inflation issue 1
Balloon burst 1
Loss of or failure to bond 1
Retraction problem 1
No code available 1
No Known Device Problem 1
Total Device Problems 60

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

Recalls
Manufacturer Recall Class Date Posted
1 Acclarent, Inc. II Aug-01-2013
2 Acclarent, Inc. I Mar-01-2012

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