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FDA 510(k)

Smart Set

K-Number: K151250 · 2016-06-07

ApplicantTop Spins, Inc.
Decision Date2016-06-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Smart Set is the device name listed in this FDA 510(k) record. The listed applicant is Top Spins, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K151250. 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 Smart Set?

Smart Set is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Top Spins, Inc.. The 510(k) number is K151250.

When did Smart Set receive FDA 510(k) clearance?

Smart Set received FDA 510(k) clearance on 2016-06-07, under 510(k) number K151250.

Who is the listed applicant for Smart Set?

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

What is the FDA product code for Smart Set?

The FDA product code for Smart Set is FPA.

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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