K231957
- 510(k) number
- K231957
- Device name
- SafeBreak® Vascular
- Applicant
- Lineus Medical AZ · US
- Product code
- QOI — Intravenous Catheter Force-Activated Separation Devi
- Decision date
- 2023-09-29
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231957.pdf
Official FDA record: K231957
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.