Cleared Special

DLP Silicone Coronary Artery Ostial Cannulae

K231206 · Medtronic, Inc. · Cardiovascular

Dec 2023

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K231206 is an FDA 510(k) clearance for the DLP Silicone Coronary Artery Ostial Cannulae, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 7, 2023, 224 days after receiving the submission on April 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K231206 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 2023
Decision Date	December 07, 2023
Days to Decision	224 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