K261041
- 510(k) number
- K261041
- Device name
- ClearSafe Closed System
- Applicant
- MedSource Labs, LLC MN · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2026-07-10
- Date received
- 2026-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261041.pdf
Official FDA record: K261041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.