Cleared Special

R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)

K240193 · Sorin Group Italia S.R.L. · Cardiovascular

Feb 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K240193 is an FDA 510(k) clearance for the R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Sorin Group Italia S.R.L. (Mirandola ( Modena), IT). The FDA issued a Cleared decision on February 22, 2024, 29 days after receiving the submission on January 24, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K240193 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2024
Decision Date	February 22, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210