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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Product CodeDTL
Regulation Number 870.4290
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 4
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 9
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 3
SEDAT
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZERUSA LIMITED
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Leak 45
Air leak 9
Fluid leak 4
Unable to obtain readings 4
Use of Device Issue 3
Other (for use when an appropriate device code cannot be identified) 3
Device operates differently than expected 3
Improper device output 3
Device Issue 2
Tear, rip or hole in device packaging 2
Defective item 2
Insufficient flow or underinfusion 2
Mechanical issue 2
Delivered as unsterile product 2
Unsealed device packaging 2
Component(s), broken 2
Decoupling 1
Disconnection 1
Hole in material 1
Excess flow or overinfusion 1
Difficult to insert 1
Kinked 1
User used incorrect product for intended use 1
Mislabeled 1
Adaptor, failure of 1
Improper or incorrect procedure or method 1
Implant Mobility NOS (Not otherwise specified) 1
Connection issue 1
Contamination of device ingredient or reagent 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Component missing 1
Malfunction 1
Device packaging compromised 1
Filtration issue 1
Improper flow or infusion 1
No flow 1
No Known Device Problem 1
Output issue 1
Pressure issue 1
Not Applicable 1
Total Device Problems 115

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 1
Class II 1 1 0 1 2 2 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jul-12-2011
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Feb-01-2007
3 Dokitz NovoSci II Nov-06-2014
4 Edwards Lifesciences Llc II Dec-07-2010
5 Medtronic Inc. Cardiac Rhythm Managment II Sep-30-2008
6 Sorin Group USA, Inc. II Oct-25-2012
7 Terumo Cardiovascular Systems Corp II Jun-23-2015
8 Thomas Medical Products Inc II Feb-14-2011
9 Vascular Solutions, Inc. I Apr-07-2016
10 Vascular Solutions, Inc. I Mar-20-2013
11 Vascular Solutions, Inc. II Sep-17-2012

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