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510(k) K861156

HOSPAL DIALYSATE FOR CAVHD by Hospal Medical Corp. — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1986
Date Received
March 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Hospal Medical Corp.

  • K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER (July 24, 1989)
  • K884365 — MULTIFLOW(TM) 60 KIT (December 8, 1988)
  • K884326 — FILTRAL TM 8 HEMODIALYZER (December 5, 1988)
  • K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (October 12, 1988)
  • K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (December 29, 1987)
  • K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (April 30, 1987)
  • K863961 — HOSPAL BIOSPAL 1800S (December 17, 1986)
  • K863592 — DISSCAP 80E, 110E, 140E, 160E (September 25, 1986)
  • K861230 — MONITRAL S (April 25, 1986)
  • K854951 — PLUME Y SET (January 8, 1986)

Other clearances for product code KPO

  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)