Home / 510(k) Clearances / K831453

510(k) K831453

SILCATH CENTRAL CATHETER TRAY W/18 GA by Argon Medical Corp. — Product Code JCY

K831453 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "SILCATH CENTRAL CATHETER TRAY W/18 GA". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Argon Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
May 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Infusion
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
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 JCY

  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K834615 — TRIPLE LUMEN INFUSIONCATHETERS- (February 14, 1984)
  • K831451 — SILCATH CENTRAL CATHETER TRAY SIZE- (June 8, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K813606 — SILICONE ELASTOMER INFUSION CATHETER (January 18, 1982)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K771861 — CATHETER, CEBTRAL VENOUS, 2N1501 (November 28, 1977)
  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)
  • K760380 — INTRAVENOUS TRANSFER SET (INTRAFIX) (November 2, 1976)

FDA data resources