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510(k) K890717

MODIFICATION HEMOFILTRATION CATHETER HF-100 by Vas-Cath, Inc. — Product Code LFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1989
Date Received
February 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Femoral
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)
  • K862771 — MEDCOMP C.A.V.H. CATHETER (August 6, 1986)