SafeBreak Vascular— 510(k) K222791

Name: FDA 510(k) clearance K222791
Creator: U.S. Food and Drug Administration
Published: 2022-10-16

Substantially Equivalent

Lineus Medical, LLC

FDA 510(k) clearance K222791 for SafeBreak Vascular, Substantially Equivalent on 2022-10-16. Applicant: Lineus Medical, LLC. Device class: 2.

Clearance details

Applicant: Lineus Medical, LLC
Product code: Code QOI
Device class: Class 2
Regulation: 21 CFR 880.5220
Advisory panel: General Hospital
Date received: 2022-09-15
Decision date: 2022-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Fayetteville, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOI

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K241415 — Orchid Safety Release Valve2024-09-06
K232094 — Orchid Safety Release ValveTM2023-10-03
K231957 — SafeBreak® Vascular2023-09-29
K223486 — SafeBreak® Vascular2023-05-19
K230266 — Orchid Safety Release Valve2023-05-04

Adverse events under product code QOI

product code QOI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.