meddevicedb.com FDA Device Reference

BraidE Embolization Assist Device

DEN230064 Class II Direct
Decision Date
2024-02-21
Sponsor / Applicant
Rapid Medical Ltd.

Technical Specification

510(k) Submission ID DEN230064
Product Code QZU
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.3325
Decision Date 2024-02-21
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

BraidE Embolization Assist Device received FDA 510(k) clearance under submission number DEN230064, sponsored by Rapid Medical Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-02-21.

Classification & Regulation

This clearance is catalogued under FDA product code QZU and 21 CFR 870.3325, within the Cardiovascular review panel as a Class II device.