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

CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER

K Number: K865029 · Decision Apr 17, 1987
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
206
Review Days
115

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Basic Information

Device Name
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K Number
K865029
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Travenol Laboratories, S.A.
Date Received
December 23, 1986
Decision Date
April 17, 1987
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

Similar 510(k) Clearances

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Other Clearances by Travenol Laboratories, S.A.

K Number Device Name
K874181 BAXTER BEDSIDE SYSTEM
K873894 CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873873 RESUBMITTED MICRON TRANSFUSION FILTER
K873984 AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K871908 IV ADMINISTRATION SET
K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K870169 CAPILLARY FLOW DIALYZERS
Search all 206 clearances from Travenol Laboratories, S.A. →