Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae

Q: What is the product code of K974259?

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.

FDA 510(k) K974259 · Edwards Lifesciences Research Medical

Substantially Equivalent

510(k) numberK974259

Submission

Device name: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae
Applicant: Edwards Lifesciences Research Medical
Midvale, UT, US
Received: November 13, 1997
Decision date: December 1, 1998
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)	Device	Applicant	Decision
K260195	Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special	Medtronic, Inc.	04/23/2026SE
K250937	Venous Return CannulaeDWF · Traditional	LivaNova USA, Inc.	03/11/2026SE
K260043	Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)DWF · Traditional	Smart Reactors	02/23/2026SE
K253203	Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional	Medtronic, Inc.	02/19/2026SE
K253671	Dual Stage Venous CannulaeDWF · Traditional	Sorin Group Italia S.R.L.	01/30/2026SE
K253998	Clearview Intracoronary ShuntsDWF · Special	Medtronic, Inc.	01/20/2026SE
K253106	AngioVac CannulaDWF · Special	AngioDynamics, Inc.	10/24/2025SE
K250283	RAP Femoral Venous CannulaeDWF · Special	LivaNova USA, Inc.	07/10/2025SE
K250610	Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special	Sorin Group Italia S.R.L.	06/27/2025SE
K251258	MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous CannulaDWF · Traditional	Medtronic, Inc.	06/20/2025SE

More from Medtronic, Inc.

510(k)	Device	Decision
K073559	18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula IIDQR · Special	01/31/2008SE
K062429	Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with…DTM · Traditional	09/27/2006SE
K990396	T-AnastafloDWF · Traditional	10/01/1999SE
K991170	Retrograde Cardioplegia Cannula with Duraflo Treatment, Model DII-RC-014DWF · Traditional	07/02/1999SE
K983791	Peripheral Retrograde Cardiaplegia CannulaDWF · Traditional	06/11/1999SE

Questions and answers

When was Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae cleared by the FDA?

Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae (K974259) received a 510(k) decision of Substantially Equivalent on December 1, 1998, 383 days after the submission was received.

What is the product code of K974259?

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.