Cleared Special

Clearview Intracoronary Shunts

K253998 · Medtronic, Inc. · Cardiovascular

Jan 2026

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K253998 is an FDA 510(k) clearance for the Clearview Intracoronary Shunts, 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 January 20, 2026, 39 days after receiving the submission on December 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K253998 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2025
Decision Date	January 20, 2026
Days to Decision	39 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