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510(k) K981198

MEDTRONIC ZUMA GUIDING CATHETER by Medtronics Interventional Vascular — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1998
Date Received
April 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Medtronics Interventional Vascular

  • K990707 — MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS (March 22, 1999)
  • K980973 — MEDTRONIC ANGIOGRAPHIC CATHETER (December 10, 1998)
  • K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (September 4, 1998)
  • 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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