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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 a medical device manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2017-05-31 under approval 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. It is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K162601.

When was Infusion Set for Single Use approved by the FDA?

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

What company makes Infusion Set for Single Use?

Infusion Set for Single Use is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd..

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

The FDA product code for Infusion Set for Single Use is FPA.

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Other Devices by Shinva Ande Healthcare Apparatus Co., Ltd.

K193657Disposable Enteral Feeding Syringe with Enfit Connector K202060Disposable IV catheter K201460Closed System Transfer Device K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

Related Devices (Code: FPA)

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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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