K233702
- 510(k) number
- K233702
- Device name
- SMARxT Tubing and Connectors
- Applicant
- LivaNova USA, Inc. CO · US
- Product code
- DWE — Tubing, Pump, Cardiopulmonary Bypass
- Decision date
- 2024-08-08
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233702.pdf
Official FDA record: K233702
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.