Submission Details
| 510(k) Number | K253671 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2025 |
| Decision Date | January 30, 2026 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Dual Stage Venous Cannulae
Jan 2026
Decision
70d
Days
Class 2
Risk
About This 510(k) Submission
K253671 is an FDA 510(k) clearance for the Dual Stage Venous Cannulae, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on January 30, 2026, 70 days after receiving the submission on November 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Manufacturer
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