K260043
- 510(k) number
- K260043
- Device name
- Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
- Applicant
- Smart Reactors IE
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2026-02-23
- Date received
- 2026-01-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260043.pdf
Official FDA record: K260043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.