Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit

Q: What is the product code of K052524?

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) K052524 · Medtronic Perfusion Systems

Substantially Equivalent

510(k) numberK052524

Submission

Device name: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit
Applicant: Medtronic Perfusion Systems
Minneapolis, MN, US
Received: September 14, 2005
Decision date: November 22, 2005
Decision: Substantially Equivalent (SESE)
Type: Special 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
K240666	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional	07/10/2024SE
K181954	autoLog IQ Autotransfusion SystemCAC · Special	08/22/2018SE
K123351	Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceDTM · Traditional	03/19/2013SE
K101186	Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagDTP · Traditional	09/03/2010SE
K090869	Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…DWF · Traditional	08/27/2009SE
K080824	Bio-Console 560DWA · Traditional	05/07/2008SE
K061254	Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222DWF · Special	06/23/2006SE
K052372	MC2X Multi-Stage Venous Cannula, Models 91437, 91437CDWF · Special	09/22/2005SE
K051303	Bio-Console, Model 560DWA · Special	06/10/2005SE
K051040	Heparin Dose Response Controls, Model 306-20 PorJOX · Special	05/24/2005SE

Questions and answers

When was Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit cleared by the FDA?

Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (K052524) received a 510(k) decision of Substantially Equivalent on November 22, 2005, 69 days after the submission was received.

What is the product code of K052524?

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.