510(k) clearance

Tri Stage Venous Cannulae

FDA 510(k) source

510(k) number

K262052

Applicant

Sorin Group Italia S.R.L.

Decision date

Sep 28, 2026

Date received

Jun 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

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