FDA PMA

Embolization Agent, Vascular

PMA Number: P220020 · 2026-07-09

ApplicantSirtex Medical, Inc.

Decision Date2026-07-09

PMA NumberP220020

Product CodeQVG

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

Embolization Agent, Vascular is the device name listed in this FDA 510(k) record. The listed applicant is Sirtex Medical, Inc.. It received FDA 510(k) clearance on 2026-07-09. The device is classified under product code QVG. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Embolization Agent, Vascular?

Embolization Agent, Vascular is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Sirtex Medical, Inc..

When did Embolization Agent, Vascular receive FDA 510(k) clearance?

The clearance date for Embolization Agent, Vascular can be found in the official FDA records.

Who is the listed applicant for Embolization Agent, Vascular?

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

What is the FDA product code for Embolization Agent, Vascular?

The FDA product code for Embolization Agent, Vascular is QVG.

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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.