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FDA PMA

Intrasaccular Flow Disruption Device

PMA Number: P170032 · 2026-05-01

ApplicantMicroVention, Inc.
Decision Date2026-05-01
PMA NumberP170032
Product CodeOPR
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

Intrasaccular Flow Disruption Device is a medical device manufactured by MicroVention, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-01 under PMA number P170032. The device is classified under FDA product code OPR. It was reviewed by the NE advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Intrasaccular Flow Disruption Device?

Intrasaccular Flow Disruption Device is a medical device that received FDA Premarket Approval (PMA) on 2026-05-01. It is manufactured by MicroVention, Inc.. The PMA number is P170032.

When did Intrasaccular Flow Disruption Device receive FDA PMA approval?

Intrasaccular Flow Disruption Device received FDA PMA approval on 2026-05-01, under approval number P170032.

What company makes Intrasaccular Flow Disruption Device?

Intrasaccular Flow Disruption Device is manufactured by MicroVention, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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

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

What FDA device class is Intrasaccular Flow Disruption Device?

Intrasaccular Flow Disruption Device is classified as Class III by the FDA.

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.

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