Cleared Traditional

Retrograde Coronary Sinus Perfusion Cannulae

K253203 · Medtronic, Inc. · Cardiovascular

Feb 2026

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K253203 is an FDA 510(k) clearance for the Retrograde Coronary Sinus Perfusion Cannulae, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on February 19, 2026, 146 days after receiving the submission on September 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K253203 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	February 19, 2026
Days to Decision	146 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