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510(k) K150219

Equashield Closed System drug Transfer Device (CSTD) by Equashield Medical , Ltd. — Product Code ONB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2015
Date Received
January 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

Other clearances by Equashield Medical , Ltd.

  • K221513 — Equashield Closed System Transfer Device (February 17, 2023)
  • K170706 — Equashield Closed System drug Transfer Device (CSTD) (July 3, 2017)
  • K132899 — EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) (May 13, 2014)
  • K101940 — EQUASHIELD SYSTEM PROTECTIVE PLUS (November 19, 2010)

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