K242092
- 510(k) number
- K242092
- Device name
- MICRO Arterial Filters
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Decision date
- 2024-11-18
- Date received
- 2024-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242092.pdf
Official FDA record: K242092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.