510(k) K260043
K260043 is an FDA 510(k) premarket notification submitted by Smart Reactors for the device "Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)". The FDA issued a decision of Substantially Equivalent on February 23, 2026. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2026
- Date Received
- January 7, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4210
- Review Panel
- CV
- Submission Type