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510(k) K842039

ARGON DUAL LUMEN HEMODIALYSIS, CATHETER by Argon Medical Corp. — Product Code KNZ

K842039 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "ARGON DUAL LUMEN HEMODIALYSIS, CATHETER". The FDA issued a decision of Substantially Equivalent on January 29, 1985. The device falls under product code KNZ (Accessories, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Argon Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1985
Date Received
May 21, 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 Argon Medical Corp.

  • K130730 — V-STICK VASCULAR ACCESS SET (November 22, 2013)
  • K904994 — CLOSED SYSTEM FLUSH SET (January 15, 1991)
  • K895511 — CATHETER BALLOON DILATOR PRESSURE GAUGE (February 28, 1990)
  • K894157 — OBTURATOR (September 28, 1989)
  • K891022 — INTRODUCER FOR PTCA GUIDING CATHETERS (May 19, 1989)
  • K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (January 11, 1989)
  • K882221 — OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE (August 12, 1988)
  • K871297 — KADIR HI-TORQUE GUIDE WIRE (April 10, 1987)
  • K853312 — ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (September 12, 1985)
  • K852880 — PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) (August 29, 1985)

Other clearances for product code KNZ

  • 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)
  • 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