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

ULTIPOR SOLUTION CONTAINER FILTER

K Number: K790879 · Decision Jun 1, 1979
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
28
Review Days
25

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Basic Information

Device Name
ULTIPOR SOLUTION CONTAINER FILTER
K Number
K790879
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Pall Biomedical Products Co.
Date Received
May 7, 1979
Decision Date
June 1, 1979
Product Code
FPB
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
FPB Filter, Infusion Line

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Other Clearances by Pall Biomedical Products Co.

K Number Device Name
K954331 PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K960993 PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K905794 PALL 3N1 FILTER
K902518 LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K884534 PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
K875095 PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
K875094 ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K873667 PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
K873666 PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K874405 PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
Search all 28 clearances from Pall Biomedical Products Co. →