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PMA de la FDA

Intrasaccular Flow Disruption Device

Número de PMA: P170032 · 2026-05-28

SolicitanteMicroVention, Inc.
Fecha de decisión2026-05-28
Número PMAP170032
Código de productoOPR
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorNE

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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