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510(k) K223607

Plum Duo™ Infusion System by Icu Medical, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
December 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K190157 — Diana ChemoClave Transfer Set (October 23, 2019)

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  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
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