• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 6
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 17
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
Infusion or flow issue 27
Other (for use when an appropriate device code cannot be identified) 20
Fluid leak 15
Leak 13
Device operates differently than expected 13
Pumping stopped 10
Break 8
Suction issue 8
No Information 7
Disconnection 6
Air leak 5
Detachment of device component 5
Disassembly 4
Performance 4
Unknown (for use when the device problem is not known) 4
No Known Device Problem 4
Inadequate filtration process 4
Device Issue 4
Tear, rip or hole in device packaging 3
Unsealed device packaging 3
Material integrity issue 2
No flow 2
Device displays error message 2
Device inoperable 2
Vacuum, loss of 2
Filter break(s) 2
Fracture 2
Hole in material 2
Crack 2
Decrease in suction 2
Clumping in device or device ingredient 2
Blockage within device or device component 1
Computer software issue 1
Kinked 1
Foreign material 1
Explode 1
Improper or incorrect procedure or method 1
Noise 1
Use of Device Issue 1
Invalid sensing 1
Tube(s), defective 1
Component missing 1
Failure to pump 1
Loose or intermittent connection 1
Inappropriate shock 1
Device stops intermittently 1
Tears, rips, holes in device, device material 1
Tubing, incorrect placement of 1
Biocompatibility issue 1
Detachment of device or device component 1
Difficult to open or close 1
Failure to shut off 1
Incompatibility problem 1
Not Applicable 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 213

-
-