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Equashield Closed System drug Transfer Device (CSTD)

by Equashield Medical Ltd 3 variants

510(k) K150219

Equashield Closed System drug Transfer Device (CSTD) is a Class II device made by Equashield Medical Ltd, cleared under FDA 510(k) K150219 on 5 Nov 2015, active as of 23 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150219 Date5 Nov 2015ClearedStatusActive

Official records

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  • Withdrawn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
ONB
FDA applicant
Equashield Medical , Ltd.
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System).

Other devices from Equashield Medical Ltd

See all devices from Equashield Medical Ltd →