510(k) K262052
K262052 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "Tri Stage Venous Cannulae". The FDA issued a decision of Substantially Equivalent on Sep 28, 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 62 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2026
- Date Received
- Jun 18, 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
- 510(k)