510(k) clearance

Dual Stage Venous Cannulae

FDA 510(k) source

510(k) number

K263092

Applicant

Sorin Group Italia S.R.L.

Decision date

Oct 1, 2026

Date received

Sep 3, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

DWF

Device type

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device class

Class II

Regulation

21 CFR 870.4210

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Mirandola, IT