SafeBreak Vascular— 510(k) DEN190043
UnknownSite Saver, Inc. D/B/A Lineus Medical
FDA 510(k) clearance DEN190043 for SafeBreak Vascular, Unknown on 2021-05-27. Applicant: Site Saver, Inc. D/B/A Lineus Medical.
Clearance details
- Applicant
- Site Saver, Inc. D/B/A Lineus Medical
- Product code
- Code QOI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Fayetteville, AR, 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.