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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, vascular graft, of 6mm and greater diameter
Regulation Description Vascular graft prosthesis.
Product CodeDSY
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 16
BAXTER HEALTHCARE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  4
  SUBSTANTIALLY EQUIVALENT 14
CARBOMEDICS, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INTER-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K893459  PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
  2.  K894732  VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
  3.  K896964  PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
  4.  K914116  PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 5
SULZER
  SUBSTANTIALLY EQUIVALENT 4
TAYSIDE FLOW TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCUTEK LTD.
  3
  SUBSTANTIALLY EQUIVALENT 14
W.L. GORE & ASSOCIATES,INC
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  5
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
Leak 123
No code available 118
Manufacturing or shipping issue associated with device 51
No Information 48
Occlusion within device 42
Device operates differently than expected 42
No Known Device Problem 35
Other (for use when an appropriate device code cannot be identified) 34
Device remains implanted 34
Device clogged 30
Unknown (for use when the device problem is not known) 23
Tears, rips, holes in device, device material 21
Hole in material 20
Torn material 17
Peeled 16
Mislabeled 14
Unraveled material 13
Foreign material 13
Explanted 11
Delamination 9
Material frayed 7
Migration of device or device component 6
Product quality issue 6
Replace 5
Blockage within device or device component 5
Split 5
Kinked 4
Material rupture 4
Foreign material present in device 4
Size incorrect for patient 4
Material separation 4
Repair 3
Material deformation 3
Detachment of device component 3
Entrapment of device or device component 3
Break 3
Material perforation 2
Reaction 2
Fungus in device environment 2
Sticking 2
Device packaging compromised 2
Elective replacement 2
Deployment issue 2
Material puncture 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Contamination during use 2
Elective removal 2
Fracture 2
Human-Device Interface Issue 2
Infusion or flow issue 1
Difficult to remove 1
Fire 1
Failure to remove enzymatic cleaner 1
Material discolored 1
Tear, rip or hole in device packaging 1
Material integrity issue 1
Device inoperable 1
Melted 1
Surgical graft, failure of 1
Coagulation in device or device ingredient 1
Material Protrusion 1
Design/structure problem 1
Electro-magnetic interference (EMI) 1
Out-of-box failure 1
Device Issue 1
Device or device component damaged by another device 1
Suture line separation 1
Biological environmental factor 1
Device Contamination with biological material 1
Malposition of device 1
Device markings issue 1
Loose or intermittent connection 1
Disconnection 1
Material Distortion 1
Bacterial contamination of device 1
Implant, removal of 1
Cut in material 1
Improper flow or infusion 1
Component(s), broken 1
Device expiration issue 1
Filling problem 1
Fluid leak 1
Mechanical issue 1
Nonstandard device or device component 1
Shelf life exceeded 1
Stretched 1
Total Device Problems 848

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 5 1 0 2 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-30-2013
2 Bard Peripheral Vascular Inc II Feb-09-2016
3 Intervascular S.A.S. II Apr-28-2010
4 Intervascular S.A.S. II Apr-23-2010
5 Maquet Cardiovascular, LLC II Mar-07-2011
6 Maquet Cardiovascular, LLC II Jul-22-2010
7 Maquet Cardiovascular, LLC II May-14-2010
8 Maquet Cardiovascular, LLC II Feb-26-2010
9 Terumo Cardiovascular Systems Corporation II Nov-18-2013
10 Vascutek, Ltd. II Aug-18-2014

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