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FDA PMA

Intracranial aneurysm flow diverter

PMA Number: P100018 · 2026-07-21

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2026-07-21
PMA NumberP100018
Product CodeOUT
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

Intracranial aneurysm flow diverter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code OUT. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Intracranial aneurysm flow diverter?

Intracranial aneurysm flow diverter is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

When did Intracranial aneurysm flow diverter receive FDA 510(k) clearance?

The clearance date for Intracranial aneurysm flow diverter can be found in the official FDA records.

Who is the listed applicant for Intracranial aneurysm flow diverter?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intracranial aneurysm flow diverter?

The FDA product code for Intracranial aneurysm flow diverter is OUT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

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