K241248
- 510(k) number
- K241248
- Device name
- Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
- Applicant
- Spectrum Medical S.R.L. IT
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2024-05-31
- Date received
- 2024-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241248.pdf
Official FDA record: K241248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.