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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter and tip, suction
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeJOL
Regulation Number 880.6740
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APLICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT WITH DRUG 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
PRIMARY CARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
VITAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 14
Detachment of device component 11
No Known Device Problem 9
Fluid leak 6
Leak 4
User used incorrect product for intended use 3
Tip breakage 3
Material fragmentation 3
Component(s), broken 3
Unknown (for use when the device problem is not known) 2
Aspiration issue 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 60

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

Recalls
Manufacturer Recall Class Date Posted
1 Invuity, Inc. II Oct-03-2012

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