DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4210 · Class 2
Overview
| Product Code | DWF |
|---|---|
| Device Name | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4210 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 400)
Showing 20 most recent of 400 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | Mar 11, 2026 | SESE |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | Feb 23, 2026 | SESE |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | Feb 19, 2026 | SESE |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | Jan 30, 2026 | SESE |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | Jan 20, 2026 | SESE |
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | Oct 24, 2025 | SESE |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | Jul 10, 2025 | SESE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | Jun 27, 2025 | SESE |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Medtronic, Inc. | Jun 20, 2025 | SESE |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | May 31, 2024 | SESE |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | Sorin Group Italia S.R.L. | Feb 22, 2024 | SESE |
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); | Edwards Lifesciences | Feb 5, 2024 | SESE |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | Dec 7, 2023 | SESE |
| K230960 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | May 4, 2023 | SESE |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS | Qura S.R.L | Aug 18, 2022 | SESE |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Qura S.R.L | May 20, 2022 | SESE |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | Qura S.R.L | Nov 8, 2021 | SESE |
| K212386 | AngioVac F18 85 | AngioDynamics, Inc. | Sep 30, 2021 | SESE |
| K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | Jul 15, 2021 | SESE |
| K203057 | Quantum Perfusion Arterial Cannula Graft | Qura S.R.L | Jun 30, 2021 | SESE |
Top Applicants
- Medtronic, Inc. — 30 clearances
- Dlp, Inc. — 22 clearances
- Shiley, Inc. — 21 clearances
- 3M Health Care, Sarns — 21 clearances
- Edwards Lifesciences, LLC — 18 clearances
