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FDA 510(k)

SURGEN VALVE

K-Number: K990331 · 2000-05-31

ApplicantTiva Medical
Decision Date2000-05-31
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGEN VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Tiva Medical. It received FDA 510(k) clearance on 2000-05-31 under 510(k) number K990331. 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 SURGEN VALVE?

SURGEN VALVE is a medical device that received FDA 510(k) clearance on 2000-05-31. The listed applicant is Tiva Medical. The 510(k) number is K990331.

When did SURGEN VALVE receive FDA 510(k) clearance?

SURGEN VALVE received FDA 510(k) clearance on 2000-05-31, under 510(k) number K990331.

Who is the listed applicant for SURGEN VALVE?

The FDA 510(k) record lists Tiva Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGEN VALVE?

The FDA product code for SURGEN VALVE is FPA.

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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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure 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)

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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