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510(k) K880775

CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY by Medsurg Industries, Inc. — Product Code LFK

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
July 25, 1988
Date Received
February 26, 1988
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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  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K925558 — INFILTUBE (March 4, 1994)
  • K934971 — STERILE LAPAROTOMY SPONGES (February 7, 1994)
  • K920421 — MEDSURG MARSHMALLOW TRAY (December 13, 1993)
  • K920838 — MEDSURG CIRCUMCISION TRAY (October 15, 1993)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K914037 — MEDSURG O.R. PROCEDURE TRAY (June 22, 1993)
  • K914036 — MEDSURG LAPAROSCOPY TRAY (March 18, 1992)

Other clearances for product code LFK

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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)
  • K882466 — VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (July 13, 1988)
  • K865096 — NEW SECOND FRENCH SIZE MAHURKAR CATHETER (February 18, 1987)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)
  • K862771 — MEDCOMP C.A.V.H. CATHETER (August 6, 1986)