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FDA 510(k)

Velano ExT Extension Set

K-Number: K200439 · 2021-02-23

ApplicantVelano Vascular
Decision Date2021-02-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Velano ExT Extension Set is the device name listed in this FDA 510(k) record. The listed applicant is Velano Vascular. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K200439. 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 Velano ExT Extension Set?

Velano ExT Extension Set is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Velano Vascular. The 510(k) number is K200439.

When did Velano ExT Extension Set receive FDA 510(k) clearance?

Velano ExT Extension Set received FDA 510(k) clearance on 2021-02-23, under 510(k) number K200439.

Who is the listed applicant for Velano ExT Extension Set?

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

What is the FDA product code for Velano ExT Extension Set?

The FDA product code for Velano ExT Extension Set is FPA.

Other records listing Velano Vascular 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.

K201237Velano Vascular Blood Collection AdapterK193569PIVO(TM)K190604PIVOK182897Velano Vascular Q2 Extension SetK163508PIVOK152924TIVA¿

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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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