FDA 510(k)

SafeBreak® Vascular

K-Number: K223486 · 2023-05-19

Decision Date2023-05-19

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. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K223486. 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 2023-05-19. The listed applicant is Lineus Medical. The 510(k) number is K223486.

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

SafeBreak® Vascular received FDA 510(k) clearance on 2023-05-19, under 510(k) number K223486.

Who is the listed applicant for SafeBreak® Vascular?

The FDA 510(k) record lists Lineus Medical 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 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 K222791SafeBreak Vascular

Related Devices (Code: QOI)

K241415Orchid Safety Release Valve™Linear Health Sciences, LLC K232094Orchid Safety Release ValveTMLinear Health Sciences, LLC K231957SafeBreak® VascularLineus Medical K230266Orchid Safety Release ValveLinear Health Sciences, LLC K222791SafeBreak VascularLineus Medical, 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.