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FDA 510(k)

I.V. Administration Set

K-Number: K210381 · 2021-08-14

ApplicantBq Plus Medical Co., Ltd.
Decision Date2021-08-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Bq Plus Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-08-14 under 510(k) number K210381. 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 I.V. Administration Set?

I.V. Administration Set is a medical device that received FDA 510(k) clearance on 2021-08-14. The listed applicant is Bq Plus Medical Co., Ltd.. The 510(k) number is K210381.

When did I.V. Administration Set receive FDA 510(k) clearance?

I.V. Administration Set received FDA 510(k) clearance on 2021-08-14, under 510(k) number K210381.

Who is the listed applicant for I.V. Administration Set?

The FDA 510(k) record lists Bq Plus Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. Administration Set?

The FDA product code for I.V. Administration Set is FPA.

Other records listing Bq Plus Medical 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.

K242126I.V. Administration SetK223645I.V. Administration Set, I.V. Extension Set

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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