FDA PMA

Agent, injectable, embolic

PMA Number: P030004 · 2026-08-05

ApplicantEv3 Neurovascular

Decision Date2026-08-05

PMA NumberP030004

Product CodeMFE

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeNE

Device Summary

Agent, injectable, embolic is the device name listed in this FDA 510(k) record. The listed applicant is Ev3 Neurovascular. It received FDA 510(k) clearance on 2026-08-05. The device is classified under product code MFE. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Agent, injectable, embolic?

Agent, injectable, embolic is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Ev3 Neurovascular.

When did Agent, injectable, embolic receive FDA 510(k) clearance?

The clearance date for Agent, injectable, embolic can be found in the official FDA records.

Who is the listed applicant for Agent, injectable, embolic?

The FDA 510(k) record lists Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agent, injectable, embolic?

The FDA product code for Agent, injectable, embolic is MFE.

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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.