K231362
- 510(k) number
- K231362
- Device name
- OCS Heart Leukocyte Depleting Filter
- Applicant
- TransMedics, Inc. MA · US
- Product code
- DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Decision date
- 2023-10-31
- Date received
- 2023-05-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K231362.pdf
Official FDA record: K231362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.