FDA 510(k)

Velano ExT Extension Set

K-Number: K200439 · 2021-02-23

Decision Date2021-02-23

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Velano ExT Extension Set is a medical device manufactured by Velano Vascular. It received FDA 510(k) clearance on 2021-02-23 under approval 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. It is manufactured by Velano Vascular. The 510(k) number is K200439.

When was Velano ExT Extension Set approved by the FDA?

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

What company makes Velano ExT Extension Set?

Velano ExT Extension Set is manufactured by Velano Vascular.

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

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

Other Devices by Velano Vascular

K152924TIVA¿ K163508PIVO K190604PIVO K182897Velano Vascular Q2 Extension Set K193569PIVO(TM)

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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.