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Bio-Medicus Pediatric Cannula and Introducers

by Medtronic, Inc.

510(k) K143083

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143083 Date25 Mar 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0640-2018 FDA Class II initiated 21 Sep 2017 on shared 510(k) K143083

    Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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