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510(k) K903606

GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER by North American Instrument Corp. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1990
Date Received
July 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • 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)

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