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510(k) K960983

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

K960983 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT". The FDA issued a decision of Substantially Equivalent on May 30, 1996. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Medtronics Interventional Vascular has at least 10 other 510(k) clearances on record.

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

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)
  • 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)
  • 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

  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • 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)

FDA data resources