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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
  1.  K004011  IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASC ...
  2.  K050049  DYNAFLO BYPASS GRAFT
  3.  K052282  VENAFLO II VASCULAR GRAFT
  4.  K800149  USCI SAUVAGE EXS VASCULAR PROSTHESIS
  5.  K801156  USCI INTRALUMINAL GRAFT W/DACRON TIE
  6.  K801621  VASCULAR GRAFT PROSTH. OF EXP. MICRO.
  7.  K821716  BARD PTFE VASCULAR PROSTHESIS
  8.  K830543  VASCULAR GRAFT PROSTHESIS EXPANDED MICR
  9.  K933204  BARD PTFE VASCULAR GRAFT
  10.  K964197  IMPRA CARBOFLO EPTFE VASCULAR GRAFT
  11.  K981079  VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CA ...
  12.  K983064  IMPRA HIGH POROSITY GRAFT
  13.  K983861  DISTAFLO BYPASS GRAFT
  14.  K991027  BI-DIRECTIONAL TUNNELER
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
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
Device remains implanted 34
Other (for use when an appropriate device code cannot be identified) 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
Foreign material 13
Unraveled material 13
Explanted 11
Delamination 9
Material frayed 7
Migration of device or device component 6
Product quality issue 6
Blockage within device or device component 5
Split 5
Replace 5
Material rupture 4
Material separation 4
Size incorrect for patient 4
Kinked 4
Foreign material present in device 4
Material deformation 3
Break 3
Detachment of device component 3
Entrapment of device or device component 3
Repair 3
Device packaging compromised 2
Deployment issue 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Fungus in device environment 2
Sticking 2
Material perforation 2
Elective removal 2
Elective replacement 2
Contamination during use 2
Fracture 2
Reaction 2
Material puncture 2
Human-Device Interface Issue 2
Improper flow or infusion 1
Infusion or flow issue 1
Material Distortion 1
Material integrity issue 1
Material Protrusion 1
Nonstandard device or device component 1
Loose or intermittent connection 1
Mechanical issue 1
Melted 1
Design/structure problem 1
Material discolored 1
Disconnection 1
Electro-magnetic interference (EMI) 1
Coagulation in device or device ingredient 1
Component(s), broken 1
Failure to remove enzymatic cleaner 1
Device expiration issue 1
Filling problem 1
Fire 1
Fluid leak 1
Bacterial contamination of device 1
Out-of-box failure 1
Device inoperable 1
Difficult to remove 1
Stretched 1
Suture line separation 1
Shelf life exceeded 1
Implant, removal of 1
Surgical graft, failure of 1
Device Issue 1
Tear, rip or hole in device packaging 1
Cut in material 1
Malposition of device 1
Biological environmental factor 1
Device Contamination with biological material 1
Device markings issue 1
Device or device component damaged by another device 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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