Cleared Special

RAP Femoral Venous Cannulae

K250283 · LivaNova USA, Inc. · Cardiovascular

Jul 2025

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K250283 is an FDA 510(k) clearance for the RAP Femoral Venous 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 July 10, 2025, 160 days after receiving the submission on January 31, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K250283 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2025
Decision Date	July 10, 2025
Days to Decision	160 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