510(k) DEN230064

BraidE Embolization Assist Device by Rapid Medical , Ltd. — Product Code QZU

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 21, 2024
Date Received: September 19, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Temporary Embolization Assist Device, Peripheral
Device Class: Class II
Regulation Number: 870.3325
Review Panel: CV
Submission Type

A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.

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