510(k) K253671
K253671 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "Dual Stage Venous Cannulae". The FDA issued a decision of Substantially Equivalent on January 30, 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. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2026
- Date Received
- November 21, 2025
- 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