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510(k) K832030

HEPARIN COATED STAINLESS STEEL/TEFLON by Argon Medical Corp. — Product Code DOX

K832030 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "HEPARIN COATED STAINLESS STEEL/TEFLON". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code DOX (Fluorometer, Lead (Dedicated Instruments)), a Class II device regulated under 21 CFR 862.3550. Argon Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
June 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, Lead (Dedicated Instruments)
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
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 DOX

  • K014195 — KAYAK HYDROPHILIC GUIDE WIRES (March 19, 2002)
  • K944226 — MSI PROCEDURE KIT (June 21, 1995)
  • K900822 — HYDRO-SIL(TM) COATED GUIDEWIRES (July 17, 1990)

FDA data resources