Cleared Traditional

Venous Return Cannulae

K250937 · LivaNova USA, Inc. · Cardiovascular

Mar 2026

Decision

348d

Days

Class 2

Risk

About This 510(k) Submission

K250937 is an FDA 510(k) clearance for the Venous Return Cannulae, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by LivaNova USA, Inc. (Arvada, US). The FDA issued a Cleared decision on March 11, 2026, 348 days after receiving the submission on March 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K250937 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2025
Decision Date	March 11, 2026
Days to Decision	348 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