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510(k) K852880

PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) by Argon Medical Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1985
Date Received
July 9, 1985
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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  • 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)
  • K844555 — PATHFINDER CARDIOVASCULAR CATHETER (March 27, 1985)

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