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510(k) K842864

VACCESS FEMORAL CANNULA by Vas-Cath of Canada , Ltd. — Product Code KNZ

K842864 is an FDA 510(k) premarket notification submitted by Vas-Cath of Canada , Ltd. for the device "VACCESS FEMORAL CANNULA". The FDA issued a decision of Substantially Equivalent on August 8, 1984. The device falls under product code KNZ (Accessories, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Vas-Cath of Canada , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1984
Date Received
July 23, 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 Vas-Cath of Canada , Ltd.

  • K875188 — LUER LOCK CONNECTORS / RIDIG P.V.C. (March 2, 1988)
  • K871817 — VAS-CATH PERITONEAL DIALYSIS CATHETER (July 16, 1987)
  • K871488 — VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K853283 — VACCESS TM 4006 (August 22, 1985)
  • K844854 — OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT (May 21, 1985)
  • K844800 — OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS (May 16, 1985)
  • K850009 — EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (May 13, 1985)
  • K844434 — VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (March 13, 1985)

Other clearances for product code KNZ

  • K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (January 29, 1985)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K842416 — DUO FLOW CATHETER-MC 54 (July 26, 1984)
  • K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL (June 25, 1984)
  • K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS (April 20, 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