K232480
- 510(k) number
- K232480
- Device name
- ProtekDuo Veno-Venous Cannula Sets
- Applicant
- Cardiacassist, Inc. PA · US
- Product code
- PZS — Dual Lumen Ecmo Cannula
- Decision date
- 2023-10-06
- Date received
- 2023-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232480.pdf
Official FDA record: K232480
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.