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510(k) K871297

KADIR HI-TORQUE GUIDE WIRE by Argon Medical Corp. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Argon Medical Corp.

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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)
  • 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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