FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

FILTER, TRANSFUSION BLOOD, INTERSEPT

K Number: K760222 · Decision Aug 6, 1976
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
56
Review Days
25

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Basic Information

Device Name
FILTER, TRANSFUSION BLOOD, INTERSEPT
K Number
K760222
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Surgikos, Inc.
Date Received
July 12, 1976
Decision Date
August 6, 1976
Product Code
CAK
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CAK Microfilter, Blood Transfusion

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Other Clearances by Surgikos, Inc.

K Number Device Name
K875107 HEALTH CARE EYE PROTECTION
K874653 STERILE SURGICAL SCRUB BRUSH
K861441 NEUTRALON SURGICAL GLOVES
K852870 BARRIER SURGICAL GOWN
K822535 CIDEX*DIALYZER DISINFECTING SOLUTION
K820543 BARRIER ANTIMICROBIAL INCISE DRAPE
K820542 SURGIKOS INCISE DRAPE
K811871 BACTERICIDAL INCISE DRAPE
K810316 SURGIKOS FACE MASK
K801864 BARRIER APERTURED DRAPE
Search all 56 clearances from Surgikos, Inc. →