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510(k) K863218

CYTOSTATIC FILTRATION SET by Meadox Surgimed, Inc. — Product Code LFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1987
Date Received
August 20, 1986
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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  • K902461 — MEADOX SURGIMED BIOPSY GUN AND NEEDLE (July 16, 1990)
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  • K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (March 27, 1992)
  • K891764 — FC-101 FEMORAL CATHETER GUIDE WIRE (April 7, 1989)
  • K891763 — FC-100 FEMORAL CATHETER (April 7, 1989)
  • K890717 — MODIFICATION HEMOFILTRATION CATHETER HF-100 (April 5, 1989)
  • K880775 — CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY (July 25, 1988)
  • K882466 — VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (July 13, 1988)
  • K865096 — NEW SECOND FRENCH SIZE MAHURKAR CATHETER (February 18, 1987)
  • K862771 — MEDCOMP C.A.V.H. CATHETER (August 6, 1986)