SafeBreak® Vascular— 510(k) K223486
Substantially EquivalentLineus Medical
FDA 510(k) clearance K223486 for SafeBreak® Vascular, Substantially Equivalent on 2023-05-19. Applicant: Lineus Medical.
Clearance details
- Applicant
- Lineus Medical
- Product code
- Code QOI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fayetteville, AZ, US
Adverse events under product code QOI
product code QOI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.