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FDA 510(k)

SafeBreak Vascular

K-Number: K222791 · 2022-10-16

ApplicantLineus Medical, LLC
Decision Date2022-10-16
Product CodeQOI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SafeBreak Vascular is a medical device manufactured by Lineus Medical, LLC. It received FDA 510(k) clearance on 2022-10-16 under approval number K222791. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeBreak Vascular?

SafeBreak Vascular is a medical device that received FDA 510(k) clearance on 2022-10-16. It is manufactured by Lineus Medical, LLC. The 510(k) number is K222791.

When was SafeBreak Vascular approved by the FDA?

SafeBreak Vascular received FDA 510(k) clearance on 2022-10-16, under approval number K222791.

What company makes SafeBreak Vascular?

SafeBreak Vascular is manufactured by Lineus Medical, LLC.

What is the FDA product code for SafeBreak Vascular?

The FDA product code for SafeBreak Vascular is QOI.

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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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