Home / 510(k) Clearances / K790353

510(k) K790353

ACUTE RENAL DIALYSIS TRAY by Argon Medical Corp. — Product Code FKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1979
Date Received
February 22, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Start/Stop (Including Contents), Dialysis
Device Class
Class I
Regulation Number
876.5820
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 FKG

  • K925469 — JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (May 3, 1995)
  • K871630 — KITS AND TRAYS FOR DIALYSIS USE (May 26, 1987)
  • K833780 — CAPD PREP KIT (February 9, 1984)
  • K802361 — DIALYIS START CARE KIT (January 16, 1981)
  • K792207 — PERIDIAL PERITONEAL DIALYSIS TRAY (December 10, 1979)