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510(k) K861730

ACTRIL FOR KIDNEY MACHINE DISINFECTANT by Renal Systems, Inc. — Product Code FKQ

K861730 is an FDA 510(k) premarket notification submitted by Renal Systems, Inc. for the device "ACTRIL FOR KIDNEY MACHINE DISINFECTANT". The FDA issued a decision of Substantially Equivalent on June 9, 1987. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Renal Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1987
Date Received
May 6, 1986
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)
  • K854011 — RENALFO HEMOFILTER CAVHD (November 5, 1985)
  • K844790 — RENAFLO HEMOCONCENTRATOR (May 23, 1985)
  • K843963 — DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (January 7, 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)
  • 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)
  • K860336 — HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS (March 4, 1986)

FDA data resources