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510(k) K960310

EPIC INTRODUCER SHEATH by North American Instrument Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1996
Date Received
January 22, 1996
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

Other clearances by North American Instrument Corp.

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  • K915078 — MORSE HEMOSTATIC CATHETER INTRODUCER SET (June 10, 1992)
  • K905208 — MORSE ANESTHESIA (January 10, 1992)
  • K912961 — MORSE VASCULAR INTRODUCER SET (September 11, 1991)
  • K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (April 22, 1991)
  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K904275 — MORSE BALLOON INFLATION DEVICE (January 3, 1991)
  • K903606 — GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER (September 27, 1990)

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