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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, autotransfusion
Regulation Description Autotransfusion apparatus.
Product CodeCAC
Regulation Number 868.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 12
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 10
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 7
CONMED
  SUBSTANTIALLY EQUIVALENT 3
CYTORI THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIDECO
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 5
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 15
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 11
SORIN
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K881350  CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
  2.  K914053  SYSTEM 350
  3.  K952224  STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CB ...
  4.  K970714  STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CB ...
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 20
Device operates differently than expected 11
Pumping stopped 10
Fluid leak 9
No Information 7
Leak 6
Air leak 5
Performance 4
Device Issue 4
Unknown (for use when the device problem is not known) 4
Suction issue 4
No Known Device Problem 3
Break 3
Detachment of device component 3
Inadequate filtration process 3
Clumping in device or device ingredient 2
Disconnection 2
Material integrity issue 2
No flow 2
Device displays error message 2
Filter break(s) 2
Device inoperable 2
Vacuum, loss of 2
Noise 1
Tube(s), defective 1
Component missing 1
Incompatibility problem 1
Infusion or flow issue 1
Not Applicable 1
Explode 1
Foreign material 1
Fracture 1
Computer software issue 1
Decrease in suction 1
Failure to pump 1
Loose or intermittent connection 1
Inappropriate shock 1
Tears, rips, holes in device, device material 1
Tubing, incorrect placement of 1
Total Device Problems 128

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