FDA 510(k)

PIVO(TM)

K-Number: K193569 · 2020-01-21

Decision Date2020-01-21

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PIVO(TM) is a medical device manufactured by Velano Vascular. It received FDA 510(k) clearance on 2020-01-21 under approval number K193569. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIVO(TM)?

PIVO(TM) is a medical device that received FDA 510(k) clearance on 2020-01-21. It is manufactured by Velano Vascular. The 510(k) number is K193569.

When was PIVO(TM) approved by the FDA?

PIVO(TM) received FDA 510(k) clearance on 2020-01-21, under approval number K193569.

What company makes PIVO(TM)?

PIVO(TM) is manufactured by Velano Vascular.

What is the FDA product code for PIVO(TM)?

The FDA product code for PIVO(TM) is JKA.

Other Devices by Velano Vascular

K152924TIVA¿ K163508PIVO K190604PIVO K182897Velano Vascular Q2 Extension Set K200439Velano ExT Extension Set

Related Devices (Code: JKA)

K162233Kurin Blood Culture Collection SetPathway, LLC K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company K152924TIVA¿Velano Vascular K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. K163508PIVOVelano Vascular

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.