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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K253671
Device Name Dual Stage Venous Cannulae
Applicant
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola,  IT 41037
Correspondent Contact Luigi Vecchi
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/21/2025
Decision Date 01/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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