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510(k) K841119

TOPS DISPOS. INFUSION SET/HEMODIALYSIS by Top Surgical Manufacturers Co. — Product Code KNZ

K841119 is an FDA 510(k) premarket notification submitted by Top Surgical Manufacturers Co. for the device "TOPS DISPOS. INFUSION SET/HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on April 20, 1984. The device falls under product code KNZ (Accessories, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Top Surgical Manufacturers Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1984
Date Received
March 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, A-V Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Top Surgical Manufacturers Co.

  • K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE (January 8, 1985)
  • K843415 — TOP HYPODERMIC SYRINGE LUER LOCK (December 7, 1984)
  • K843313 — TOP DISPOSABLE SPINAL NEEDLE (September 19, 1984)
  • K843414 — TOP HYPODERMIC SYRINGE PISTON (September 7, 1984)
  • K841025 — TOP DISPOSABLE INFUSION SET (March 30, 1984)
  • K832624 — TOP VENULA I.V. CATHETER SET (November 21, 1983)
  • K832625 — TOP THREE WAY STOPCOCK (October 19, 1983)
  • K832623 — TOP DISPOS. INFUSION SET/HEMODIALY (October 14, 1983)
  • K832626 — TOP STERILE DISPOS. HYPODERMIC NEEDLES (October 14, 1983)
  • K832622 — WINGED INFUSION SET (October 14, 1983)

Other clearances for product code KNZ

  • K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (January 29, 1985)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K842864 — VACCESS FEMORAL CANNULA (August 8, 1984)
  • K842416 — DUO FLOW CATHETER-MC 54 (July 26, 1984)
  • K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL (June 25, 1984)
  • K840424 — HEMOCATH REPAIR KIT (March 5, 1984)
  • K840437 — HEMASITE ACCESSORIES MODIFICATION (February 21, 1984)
  • K834510 — RENAFLO AVF SET FOR HEMODIALYSIS (February 4, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)

FDA data resources