Antegrade Cardioplegia Cannula(N-Type)

Q: What is the product code of K140569?

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) K140569 · Maquet Cardiopulmonary, AG

Substantially Equivalent

510(k) numberK140569

Submission

Device name: Antegrade Cardioplegia Cannula(N-Type)
Applicant: Maquet Cardiopulmonary, AG
Rastatt De-Bw, DE
Received: March 6, 2014
Decision date: November 19, 2014
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

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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.

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K141432	Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special	07/07/2014SE
K133598	Cardiohelp SystemDTQ · Traditional	05/21/2014SE
K133265	Quadrox-Ir Adult and Small AdultKFM · Special	11/12/2013SE
K132166	Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with…DTN · Special	10/30/2013SE
K132829	Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special	10/08/2013SE
K131666	Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingDWF · Special	07/05/2013SE
K130300	Heater-Cooler Unit Hcu 40DWC · Traditional	07/01/2013SE
K123288	HemoconcentratorKDI · Traditional	06/26/2013SE
K130639	Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)Dual…DWF · Special	05/16/2013SE

Questions and answers

When was Antegrade Cardioplegia Cannula(N-Type) cleared by the FDA?

Antegrade Cardioplegia Cannula(N-Type) (K140569) received a 510(k) decision of Substantially Equivalent on November 19, 2014, 258 days after the submission was received.

What is the product code of K140569?

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.