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FDA 510(k)

Infusion Set for Single Use

K-Number: K162601 · 2017-05-31

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2017-05-31
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infusion Set for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K162601. 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 Infusion Set for Single Use?

Infusion Set for Single Use is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K162601.

When did Infusion Set for Single Use receive FDA 510(k) clearance?

Infusion Set for Single Use received FDA 510(k) clearance on 2017-05-31, under 510(k) number K162601.

Who is the listed applicant for Infusion Set for Single Use?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infusion Set for Single Use?

The FDA product code for Infusion Set for Single Use 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.

NCT07325461Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 DiabetesCOMPLETED

Other records listing Shinva Ande Healthcare Apparatus Co., Ltd. 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

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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