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FDA 510(k)

IV Fat Emulsion Administration Sets

K-Number: K172544 · 2017-09-22

ApplicantBaxter Healthcare Corporation
Decision Date2017-09-22
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV Fat Emulsion Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K172544. 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 IV Fat Emulsion Administration Sets?

IV Fat Emulsion Administration Sets is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K172544.

When did IV Fat Emulsion Administration Sets receive FDA 510(k) clearance?

IV Fat Emulsion Administration Sets received FDA 510(k) clearance on 2017-09-22, under 510(k) number K172544.

Who is the listed applicant for IV Fat Emulsion Administration Sets?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IV Fat Emulsion Administration Sets?

The FDA product code for IV Fat Emulsion Administration Sets is FPA.

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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.

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