K240190
- 510(k) number
- K240190
- Device name
- MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- Applicant
- Medtronic MN · US
- Product code
- DTR — Heat-Exchanger, Cardiopulmonary Bypass
- Decision date
- 2024-02-23
- Date received
- 2024-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240190.pdf
Official FDA record: K240190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.