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510(k) K873421

KAWASUMI A.V. FISTULA SET by Kawasumi Laboratories Co., Ltd. — Product Code FKQ

K873421 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories Co., Ltd. for the device "KAWASUMI A.V. FISTULA SET". The FDA issued a decision of Substantially Equivalent on October 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. Kawasumi Laboratories Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
August 25, 1987
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 Kawasumi Laboratories Co., Ltd.

  • K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET (March 8, 2000)
  • K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) (February 12, 1998)
  • K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (March 14, 1997)
  • K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER (February 10, 1994)
  • K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION (February 3, 1994)
  • K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER (February 3, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921901 — PORT ACCESS INFUSION SET (September 10, 1993)
  • K921902 — PORT ACCESS NEEDLE (July 28, 1993)
  • K923323 — INTERMITTENT INJECTION SITE (July 13, 1993)

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)
  • 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)
  • K860336 — HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS (March 4, 1986)

FDA data resources