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510(k) K853312

ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES by Argon Medical Corp. — Product Code DWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1985
Date Received
August 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Biopsy, Cardiovascular
Device Class
Class I
Regulation Number
878.4800
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)
  • K852880 — PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) (August 29, 1985)
  • K844555 — PATHFINDER CARDIOVASCULAR CATHETER (March 27, 1985)

Other clearances for product code DWO

  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K921418 — ULTRA-CORE BIOPSY NEEDLES (June 19, 1992)
  • K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATION (October 30, 1991)
  • K890925 — MANAN BONE MARROW BIOPSY NEEDLE (April 11, 1989)
  • K885145 — MEDSURG GREENE NEEDLE (March 14, 1989)
  • K885149 — NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (January 26, 1989)
  • K882013 — SOFT TISSUE BIOPSY DEVICE (June 15, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (July 28, 1987)
  • K820269 — RNG SERIES ULTRASOUND NEEDLE/CATH. GDS (March 23, 1982)