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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
  1.  K014083  HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY ...
  2.  K043127  HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANS ...
  3.  K053000  HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANS ...
  4.  K101907  HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTE ...
  5.  K120586  CELL SAVER ELITE
  6.  K122262  ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYS ...
  7.  K802674  RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.
  8.  K852425  CELL SAVER SUCTION SYSTEM
  9.  K883934  CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
  10.  K893394  ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
  11.  K904041  HAEMONETICS CELL SAVER 4 PLUS
  12.  K904474  HAEMONETICS LN 200F COLLECTION RESERVOIR
  13.  K932890  CELL SAVER 5 SYSTEM
  14.  K944232  AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
  15.  K993581  HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH TH ...
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
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
Device Issue 4
Performance 4
Suction issue 4
Unknown (for use when the device problem is not known) 4
No Known Device Problem 3
Inadequate filtration process 3
Detachment of device component 3
Break 3
Vacuum, loss of 2
Disconnection 2
Device displays error message 2
No flow 2
Clumping in device or device ingredient 2
Filter break(s) 2
Device inoperable 2
Material integrity issue 2
Tube(s), defective 1
Incompatibility problem 1
Inappropriate shock 1
Infusion or flow issue 1
Foreign material 1
Fracture 1
Tears, rips, holes in device, device material 1
Noise 1
Not Applicable 1
Component missing 1
Failure to pump 1
Loose or intermittent connection 1
Computer software issue 1
Decrease in suction 1
Explode 1
Tubing, incorrect placement of 1
Total Device Problems 128

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