K241352
- 510(k) number
- K241352
- Device name
- Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2024-06-12
- Date received
- 2024-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241352.pdf
Official FDA record: K241352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.