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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microfilter, blood transfusion
Regulation Description Intravascular administration set.
Product CodeCAK
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
ASAHI
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 7
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHARTER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Unknown (for use when the device problem is not known) 5
Device operates differently than expected 4
High test results 3
No Known Device Problem 3
Increase in pressure 3
Defective component 2
No Information 2
Other (for use when an appropriate device code cannot be identified) 2
Fibrosis 1
Defective item 1
Filtration issue 1
Material integrity issue 1
Inadequate filtration process 1
Filter 1
Nonstandard device or device component 1
Material rigid or stiff 1
Source, leak(s) from 1
Tears, rips, holes in device, device material 1
Use of Device Issue 1
Total Device Problems 35

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