meddevicedb.com FDA Device Reference

SafeBreak Vascular

DEN190043 Class II Direct
Decision Date
2021-05-27
Sponsor / Applicant
Site Saver, Inc. D/B/A Lineus Medical

Technical Specification

510(k) Submission ID DEN190043
Product Code QOI
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.5220
Decision Date 2021-05-27
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

SafeBreak Vascular received FDA 510(k) clearance under submission number DEN190043, sponsored by Site Saver, Inc. D/B/A Lineus Medical. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-05-27.

Classification & Regulation

This clearance is catalogued under FDA product code QOI and 21 CFR 880.5220, within the General Hospital review panel as a Class II device.