Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4210](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4210) → DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass # DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4210 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF ## Overview - **Product Code:** DWF - **Device Name:** Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4210](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4210) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K250937.md) | Venous Return Cannulae | LivaNova USA, Inc. | Mar 11, 2026 | SESE | | [K260043](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K260043.md) | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | Feb 23, 2026 | SESE | | [K253203](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K253203.md) | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | Feb 19, 2026 | SESE | | [K253671](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K253671.md) | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | Jan 30, 2026 | SESE | | [K253998](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K253998.md) | Clearview Intracoronary Shunts | Medtronic, Inc. | Jan 20, 2026 | SESE | | [K253106](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K253106.md) | AngioVac Cannula | AngioDynamics, Inc. | Oct 24, 2025 | SESE | | [K250283](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K250283.md) | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | Jul 10, 2025 | SESE | | [K250610](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K250610.md) | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | Jun 27, 2025 | SESE | | [K251258](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K251258.md) | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula | Medtronic, Inc. | Jun 20, 2025 | SESE | | [K241248](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K241248.md) | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | May 31, 2024 | SESE | | [K240193](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K240193.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K233895.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K231206.md) | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | Dec 7, 2023 | SESE | | [K230960](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K230960.md) | DLP™ Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | May 4, 2023 | SESE | | [K221353](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K221353.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K213540.md) | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Qura S.R.L | May 20, 2022 | SESE | | [K203067](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K203067.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K212386.md) | AngioVac F18 85 | AngioDynamics, Inc. | Sep 30, 2021 | SESE | | [K201100](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K201100.md) | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | Jul 15, 2021 | SESE | | [K203057](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K203057.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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