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510(k) K894157

OBTURATOR by Argon Medical Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
June 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • 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)
  • K844555 — PATHFINDER CARDIOVASCULAR CATHETER (March 27, 1985)

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