Home / 510(k) Clearances / K854612

510(k) K854612

ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 by Med-West, Inc. — Product Code LFK

K854612 is an FDA 510(k) premarket notification submitted by Med-West, Inc. for the device "ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7". The FDA issued a decision of Substantially Equivalent (with conditions) on January 3, 1986. The device falls under product code LFK (Catheter, Femoral), a Class II device regulated under 21 CFR 876.5540. Med-West, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
January 3, 1986
Date Received
November 18, 1985
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 Med-West, Inc.

  • K880877 — CONTRAST INJECTION DEVICE (May 31, 1988)
  • K880398 — POWER TOILET ELEVATOR (March 17, 1988)
  • K874470 — MWI 400 WOUND DRESSING (December 18, 1987)
  • K872724 — SHEATH/DILATORS (September 15, 1987)
  • K852162 — MNI 400 INJECTION CAPS (June 12, 1985)
  • K842342 — MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN (June 14, 1984)
  • K832124 — CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (August 12, 1983)
  • K831828 — TEFLON FEMORAL CATHETER MWI 100,10 & (July 7, 1983)
  • K831440 — SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (June 3, 1983)
  • K831401 — SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (June 3, 1983)

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)
  • 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)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)

FDA data resources