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510(k) K210707

OnGuard2 Chemfort Closed Administration (CADM) by Simplivia Healthcare , Ltd. — Product Code ONB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
March 10, 2021
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.

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Other clearances for product code ONB

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  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251411 — Chemfort Female Luer Lock Adaptor (August 5, 2025)
  • K251340 — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (May 29, 2025)
  • K243976 — ZeroClear™ Bag Access (423100) (January 22, 2025)
  • K240517 — ProSeal™ Vented Universal Vial Adaptor (December 26, 2024)
  • K241988 — ProSeal™ Closed System Bag Access (October 23, 2024)
  • K241735 — ProSeal™ In Line Pump Set (423850) (October 10, 2024)
  • K241823 — ToxiSeal™ Vial Adaptor (August 30, 2024)