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510(k) K904994

CLOSED SYSTEM FLUSH SET by Argon Medical Corp. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1991
Date Received
November 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K852880 — PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) (August 29, 1985)
  • K844555 — PATHFINDER CARDIOVASCULAR CATHETER (March 27, 1985)

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