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510(k) K980973

MEDTRONIC ANGIOGRAPHIC CATHETER by Medtronics Interventional Vascular — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1998
Date Received
March 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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  • K972944 — MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE W (November 3, 1997)
  • K961917 — MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (November 20, 1996)
  • K960983 — MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (May 30, 1996)
  • K955651 — MEDTRONIC SHERPA GUIDING CATHETER (January 22, 1996)
  • K950490 — MEDTRONIC GC IV CORONARY GUIDING CATHETER (November 21, 1995)
  • K950179 — MEDTRONIC(R) GC III CORONARY GUIDING CATHETER (July 25, 1995)
  • K950026 — MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER (April 5, 1995)

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