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MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

by Bayer Medical Care Inc.

510(k) K192370

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 NumberK192370 Date13 Dec 2019ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0483-2021 FDA Class II initiated 5 Oct 2020

    Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

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  • Withdrawn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
DXT
FDA applicant
Bayer Medical Care, Inc.
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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