FDA 510(k)

SafeBreak Vascular

K-Number: K222791 · 2022-10-16

Decision Date2022-10-16

Product CodeQOI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SafeBreak Vascular is the device name listed in this FDA 510(k) record. The listed applicant is Lineus Medical, LLC. It received FDA 510(k) clearance on 2022-10-16 under 510(k) 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. The listed applicant is Lineus Medical, LLC. The 510(k) number is K222791.

When did SafeBreak Vascular receive FDA 510(k) clearance?

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

Who is the listed applicant for SafeBreak Vascular?

The FDA 510(k) record lists Lineus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeBreak Vascular?

The FDA product code for SafeBreak Vascular is QOI.

Other records listing Lineus Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231957SafeBreak® Vascular K223486SafeBreak® Vascular

Related Devices (Code: QOI)

K241415Orchid Safety Release Valve™Linear Health Sciences, LLC K232094Orchid Safety Release ValveTMLinear Health Sciences, LLC K231957SafeBreak® VascularLineus Medical K223486SafeBreak® VascularLineus Medical K230266Orchid Safety Release ValveLinear Health Sciences, LLC K212064Orchid Safety Release Valve(TM)Linear Health Sciences, LLC

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.