Volumat Polyethylene I.V. Administration Set
K-Number: K221121 · 2023-06-16
ApplicantFresenius Kabi
Decision Date2023-06-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Volumat Polyethylene I.V. Administration Set is a medical device manufactured by Fresenius Kabi. It received FDA 510(k) clearance on 2023-06-16 under approval number K221121. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Volumat Polyethylene I.V. Administration Set?
Volumat Polyethylene I.V. Administration Set is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Fresenius Kabi. The 510(k) number is K221121.
When was Volumat Polyethylene I.V. Administration Set approved by the FDA?
Volumat Polyethylene I.V. Administration Set received FDA 510(k) clearance on 2023-06-16, under approval number K221121.
What company makes Volumat Polyethylene I.V. Administration Set?
Volumat Polyethylene I.V. Administration Set is manufactured by Fresenius Kabi.
What is the FDA product code for Volumat Polyethylene I.V. Administration Set?
The FDA product code for Volumat Polyethylene I.V. Administration Set is FPA.
Other Devices by Fresenius Kabi
Related Devices (Code: FPA)
K160007Paclitaxel SetsBaxter Healthcare Corporation
K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc.
K161323Solution Set for Epidural UseBaxter Healthcare Corporation
K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC
K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.
K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.