Cleared Traditional

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line

K200612 · Sorin Group Italia S.R.L. · Cardiovascular

Nov 2020

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K200612 is an FDA 510(k) clearance for the R501 aortic root cannula without vent line, R502 aortic root cannula with vent line, 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 November 17, 2020, 253 days after receiving the submission on March 9, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K200612 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2020
Decision Date	November 17, 2020
Days to Decision	253 days
Submission Type	Traditional
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