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FDA PMA

Intrasaccular Flow Disruption Device

PMA Number: P170032 · 2026-05-28

ApplicantMicroVention, Inc.
Decision Date2026-05-28
PMA NumberP170032
Product CodeOPR
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

Intrasaccular Flow Disruption Device is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2026-05-28. The device is classified under product code OPR. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Intrasaccular Flow Disruption Device?

Intrasaccular Flow Disruption Device is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is MicroVention, Inc..

When did Intrasaccular Flow Disruption Device receive FDA 510(k) clearance?

The clearance date for Intrasaccular Flow Disruption Device can be found in the official FDA records.

Who is the listed applicant for Intrasaccular Flow Disruption Device?

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

What is the FDA product code for Intrasaccular Flow Disruption Device?

The FDA product code for Intrasaccular Flow Disruption Device is OPR.

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.

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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.

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