Venous Return Cannulae

FDA 510(k) K250937 · LivaNova USA, Inc.

Substantially Equivalent

510(k) numberK250937

Submission

Device name
Venous Return Cannulae
Applicant
LivaNova USA, Inc.
Arvada, CO, US
Received
March 28, 2025
Decision date
March 11, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4210
Specialty
Cardiovascular

Other 510(k)s with product code DWF

510(k)DeviceApplicantDecision
K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeDWF · Special Medtronic, Inc.04/23/2026SE
K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)DWF · Traditional Smart Reactors02/23/2026SE
K253203Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional Medtronic, Inc.02/19/2026SE
K253671Dual Stage Venous CannulaeDWF · Traditional Sorin Group Italia S.R.L.01/30/2026SE
K253998Clearview Intracoronary ShuntsDWF · Special Medtronic, Inc.01/20/2026SE
K253106AngioVac CannulaDWF · Special AngioDynamics, Inc.10/24/2025SE
K250283RAP Femoral Venous CannulaeDWF · Special LivaNova USA, Inc.07/10/2025SE
K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special Sorin Group Italia S.R.L.06/27/2025SE
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaDWF · Traditional Medtronic, Inc.06/20/2025SE
K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)DWF · Special Spectrum Medical S.R.L.05/31/2024SE

More from Spectrum Medical S.R.L.

510(k)DeviceDecision
K250283RAP Femoral Venous CannulaeDWF · Special 07/10/2025SE
K233702SMARxT Tubing and ConnectorsDWE · Traditional 08/08/2024SE

Questions and answers

When was Venous Return Cannulae cleared by the FDA?

Venous Return Cannulae (K250937) received a 510(k) decision of Substantially Equivalent on March 11, 2026, 348 days after the submission was received.

What is the product code of K250937?

The FDA product code is DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4210.