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510(k) K052764

DIACAP ULTRA DIALYSIS FLUID FILTER by B. Braun Medizintechnologie GmbH — Product Code FKQ

K052764 is an FDA 510(k) premarket notification submitted by B. Braun Medizintechnologie GmbH for the device "DIACAP ULTRA DIALYSIS FLUID FILTER". The FDA issued a decision of Substantially Equivalent on June 9, 2006. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. B. Braun Medizintechnologie GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2006
Date Received
September 30, 2005
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 B. Braun Medizintechnologie GmbH

  • K072760 — SOLCART B (January 29, 2008)
  • K071518 — DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS (August 17, 2007)

Other clearances for product code FKQ

  • 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)
  • K860297 — HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES (March 4, 1986)

FDA data resources