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510(k) K862304

DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM by Cd Medical, Inc. — Product Code FKQ

K862304 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
June 17, 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 Cd Medical, Inc.

  • K925654 — CD HOME DIALYSERVICE HEMODIALYSIS TRAY (March 30, 1994)
  • K910215 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST (April 9, 1991)
  • K901520 — WURTZ CHOLEY CLIP (TM) (June 26, 1990)
  • K894106 — DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST (November 8, 1989)
  • K884353 — ULTRX(TM) 850 ARTIFICIAL KIDNEY (December 8, 1988)
  • K880459 — 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE (April 13, 1988)
  • K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (October 23, 1987)
  • K864784 — SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS (January 20, 1987)
  • K853513 — DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY (November 6, 1985)
  • K844185 — MODIFIED C-DAK (January 3, 1985)

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)
  • 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