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510(k) K960983

MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT by Medtronics Interventional Vascular — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
March 11, 1996
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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  • 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)

Other clearances for product code MAV

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  • 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)