FDA 510(k)

PIVO

K-Number: K163508 · 2017-02-09

Decision Date2017-02-09

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PIVO is a medical device manufactured by Velano Vascular. It received FDA 510(k) clearance on 2017-02-09 under approval number K163508. 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?

PIVO is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Velano Vascular. The 510(k) number is K163508.

When was PIVO approved by the FDA?

PIVO received FDA 510(k) clearance on 2017-02-09, under approval number K163508.

What company makes PIVO?

PIVO is manufactured by Velano Vascular.

What is the FDA product code for PIVO?

The FDA product code for PIVO is JKA.

Other Devices by Velano Vascular

K152924TIVA¿ K190604PIVO K182897Velano Vascular Q2 Extension Set K193569PIVO(TM) K200439Velano ExT Extension Set

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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.