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510(k) K843963

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD by Renal Systems, Inc. — Product Code FKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1985
Date Received
October 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Renal Systems, Inc.

  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K854011 — RENALFO HEMOFILTER CAVHD (November 5, 1985)
  • K844790 — RENAFLO HEMOCONCENTRATOR (May 23, 1985)
  • K844108 — RENAL SYSTEMS PERITONEAL ACCESS SYSTEM (January 7, 1985)
  • K842258 — RENATRON (July 6, 1984)
  • K841543 — CONCENTRATE CONDUCTIVITY METER (May 22, 1984)
  • K840182 — RENAPAK CONCENTRATE MIXING SYS. (May 2, 1984)
  • K840436 — HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (February 21, 1984)
  • K840437 — HEMASITE ACCESSORIES MODIFICATION (February 21, 1984)

Other clearances for product code FKQ

  • K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER (June 9, 2006)
  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)