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FDA 510(k)

Disposable infusion set with needle

K-Number: K232475 · 2024-05-10

ApplicantShandong Zhushi Pharmaceutical Group Co., Ltd.
Decision Date2024-05-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable infusion set with needle is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K232475. 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 Disposable infusion set with needle?

Disposable infusion set with needle is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K232475.

When did Disposable infusion set with needle receive FDA 510(k) clearance?

Disposable infusion set with needle received FDA 510(k) clearance on 2024-05-10, under 510(k) number K232475.

Who is the listed applicant for Disposable infusion set with needle?

The FDA 510(k) record lists Shandong Zhushi Pharmaceutical Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable infusion set with needle?

The FDA product code for Disposable infusion set with needle is FPA.

Other records listing Shandong Zhushi Pharmaceutical Group Co., Ltd. as applicant

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.

K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needleK210510Disposable Surgical GownK210643Disposable Surgical Face MaskK210409Disposable Surgical Face MaskK203454Infrared ThermometerK203436Disposable Nitrile Examination Gloves

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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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