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510(k) K915215

CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS by Akcess Medical Products, Inc. — Product Code LFK

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 27, 1992
Date Received
November 18, 1991
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

Other clearances by Akcess Medical Products, Inc.

  • K926374 — SILICONE CATHETER REPAIR KITS (October 7, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K930630 — RIGHT ATRIAL CATHETER (February 7, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 1992)
  • K920331 — RIGHT ATRIAL CATHETER KITS (April 22, 1992)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K911333 — RIGHT ATRIAL CATHETERS (September 23, 1991)

Other clearances for product code LFK

  • K971897 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (October 21, 1997)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 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)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)
  • K862771 — MEDCOMP C.A.V.H. CATHETER (August 6, 1986)