Heartport Endoarterial Return Cannula

Q: What is the product code of K971291?

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) K971291 · Heartport, Inc.

Substantially Equivalent

510(k) numberK971291

Submission

Device name: Heartport Endoarterial Return Cannula
Applicant: Heartport, Inc.
Redwood City, CA, US
Received: April 7, 1997
Decision date: June 17, 1997
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
K994243	Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip…DWF · Special	05/05/2000SE
K981995	Quickdraw Venous CannulaDWF · Traditional	04/20/1999SE
K990772	Directflow Arterial CannulaDWF · Special	03/23/1999SE
K981009	Heartport Endopulmonary Vent CatheterDWF · Traditional	09/04/1998SE
K974736	Heartport Direct Aortic Return Cannula with IntroducerDWF · Traditional	07/15/1998SE
K974175	Heartport Endoaortic Clamp CatheterDWZ · Traditional	12/16/1997SE
K972570	Heartport Introducer SheathDYB · Traditional	10/01/1997SE
K970496	Heartport Maze System: Cryoprobe SetOCL · Traditional	05/09/1997SE
K964302	Heartport Thoracic TrocarDRC · Traditional	05/09/1997SE
K964161	Heartport Endoaortic ClampDXC · Traditional	04/04/1997SE

Questions and answers

When was Heartport Endoarterial Return Cannula cleared by the FDA?

Heartport Endoarterial Return Cannula (K971291) received a 510(k) decision of Substantially Equivalent on June 17, 1997, 71 days after the submission was received.

What is the product code of K971291?

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.