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FDA 510(k)

SafeBreak® Vascular

K-Number: K231957 · 2023-09-29

ApplicantLineus Medical
Decision Date2023-09-29
Product CodeQOI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SafeBreak® Vascular is a medical device manufactured by Lineus Medical. It received FDA 510(k) clearance on 2023-09-29 under approval number K231957. 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 2023-09-29. It is manufactured by Lineus Medical. The 510(k) number is K231957.

When was SafeBreak® Vascular approved by the FDA?

SafeBreak® Vascular received FDA 510(k) clearance on 2023-09-29, under approval number K231957.

What company makes SafeBreak® Vascular?

SafeBreak® Vascular is manufactured by Lineus Medical.

What is the FDA product code for SafeBreak® Vascular?

The FDA product code for SafeBreak® Vascular is QOI.

Other Devices by Lineus Medical

K223486SafeBreak® Vascular

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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