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FDA 510(k)

MaxZero Extension Sets with Needle-Free Connector(s)

K-Number: K193088 · 2020-10-23

ApplicantCarefusion, Inc.
Decision Date2020-10-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MaxZero Extension Sets with Needle-Free Connector(s) is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion, Inc.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K193088. 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 MaxZero Extension Sets with Needle-Free Connector(s)?

MaxZero Extension Sets with Needle-Free Connector(s) is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Carefusion, Inc.. The 510(k) number is K193088.

When did MaxZero Extension Sets with Needle-Free Connector(s) receive FDA 510(k) clearance?

MaxZero Extension Sets with Needle-Free Connector(s) received FDA 510(k) clearance on 2020-10-23, under 510(k) number K193088.

Who is the listed applicant for MaxZero Extension Sets with Needle-Free Connector(s)?

The FDA 510(k) record lists Carefusion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MaxZero Extension Sets with Needle-Free Connector(s)?

The FDA product code for MaxZero Extension Sets with Needle-Free Connector(s) is FPA.

Related Clinical Trials

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.

NCT07519304Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical TrialNOT_YET_RECRUITING

Other records listing Carefusion, Inc. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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