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Medtronic Everst 30 Inflation Device/Survival Kit

by Medtronics Interventional Vascular

510(k) K960983

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960983 Date30 May 1996ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2272-2010 FDA Unclassified (pre-2012) initiated 16 Jul 2010
    • Terminated Z-2273-2010 FDA Unclassified (pre-2012) initiated 16 Jul 2010
    • Terminated Z-2271-2010 FDA Unclassified (pre-2012) initiated 16 Jul 2010

    Product sterility may be compromised due to breach of package seal integrity.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAV
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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