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510(k) K942269

MEDTRONIC EVEREST INFLATION DEVICE by Medtronics Interventional Vascular — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1994
Date Received
May 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

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  • K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (September 4, 1998)
  • K981198 — MEDTRONIC ZUMA GUIDING CATHETER (August 7, 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)

Other clearances for product code MAV

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  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)