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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, aspirating, flexible, connecting
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeBYY
Regulation Number 880.6740
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K790419  YANKAUER & POODLE SUCTION INSTRUMENTS
  2.  K790420  SUCTION CONNECTING TUBING
VITAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material puncture 2
Other (for use when an appropriate device code cannot be identified) 1
Disconnection 1
Fluid leak 1
Total Device Problems 5

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 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Mentor Texas, Inc II Sep-05-2008

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