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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, vascular
Regulation Description Vascular clamp.
Product CodeDXC
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED VASCULAR DYNAMICS
  SUBSTANTIALLY EQUIVALENT 6
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 3
BOSS INSTRUMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
CARDIVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 5
HEBUMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTABLE DEVICES
  SUBSTANTIALLY EQUIVALENT 1
INNOVASA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MARINE POLYMER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MCPHERSON ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NONE
  SUBSTANTIALLY EQUIVALENT 1
NOVARE SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 8
SEMLER TECHNOLOGIES, INC. DBA
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENTS BELGIUM SA
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR CONTROL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 4
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fitting problem 529
Failure to deploy 250
Air leak 102
Crack 89
Other (for use when an appropriate device code cannot be identified) 61
Detachment of device component 49
Mechanical issue 43
No Known Device Problem 29
Device operates differently than expected 27
Foreign material present in device 25
Break 25
Failure to advance 22
Leak 21
Unraveled material 20
No Information 20
Deflation issue 16
Difficult to open or close 15
Misfire 13
Balloon rupture 13
Migration of device or device component 13
Material rupture 13
Bent 12
Material separation 10
Device Issue 10
Loss of or failure to bond 8
Fluid leak 8
Suction issue 7
Performance 7
Use of Device Issue 6
Decrease in pressure 5
Slippage of device or device component 5
Inflation issue 5
Difficult to deploy 5
Device disinfection or sterilization issue 5
Defective item 5
Failure to fire 5
Material integrity issue 5
Pressure issue 5
Material deformation 4
Dull 4
Balloon burst 4
Balloon leak(s) 4
Failure to Adhere or Bond 4
Hole in material 4
Source, leak(s) from 4
Failure to unfold or unwrap 4
Device, or device fragments remain in patient 3
Failure to deliver 3
Tear, rip or hole in device packaging 3
Premature deployment 3
Failure to fold 3
Loose or intermittent connection 3
Misconnection 3
Balloon asymmetrical 3
Structural problem 3
No code available 3
Unintended movement 2
Packaging issue 2
Positioning Issue 2
Leaflet disruption due to suture abrasion 2
Deployment issue 2
Device packaging compromised 2
Contamination during use 2
Burst 2
Delivered as unsterile product 2
Normal 2
Occlusion within device 2
Collapse 2
Device Difficult to Setup or Prepare 2
Misassembled 2
User used incorrect product for intended use 2
Sticking 2
Tip breakage 2
Defective component 2
Seal, defective 2
Component missing 2
Improper or incorrect procedure or method 2
Unknown (for use when the device problem is not known) 1
Material perforation 1
Valve(s), defective 1
Inadequate training 1
Transducer overheating 1
Source, detachment from 1
Unstable 1
Self-activation or keying 1
Increase in pressure 1
Kinked 1
Fracture 1
Material discolored 1
Particulates 1
Incorrect measurement 1
Mineralization 1
Device Cleaning Issue 1
Component falling 1
Failure to deliver countershock 1
Difficult to advance 1
Malposition of device 1
Application program issue 1
Computer operating system issue 1
Failure to cut 1
Total Device Problems 1635

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 1 0 0 0 0 0 0
Class II 0 0 1 0 1 0 0 1 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Aug-11-2011
2 Edwards Lifesciences Research Medical, Inc. I Nov-06-2009
3 Edwards Lifesciences Research Medical, Inc. II Jan-05-2009
4 Edwards Lifesciences, LLC II Jun-11-2015
5 Maquet Cardiovascular, LLC I Feb-01-2011
6 Merit Medical Systems, Inc. II Apr-10-2017
7 Sam Medical Products II Dec-16-2014

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