DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class II
FDA Device Classification
Classification Details
- Product Code
- DWF
- Device Class
- Class II
- Regulation Number
- 870.4210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250937 | livanova usa | Venous Return Cannulae | March 11, 2026 |
| K260043 | smart reactors | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 | February 23, 2026 |
| K253203 | medtronic | Retrograde Coronary Sinus Perfusion Cannulae | February 19, 2026 |
| K253671 | sorin group italia | Dual Stage Venous Cannulae | January 30, 2026 |
| K253998 | medtronic | Clearview Intracoronary Shunts | January 20, 2026 |
| K253106 | angiodynamics | AngioVac Cannula | October 24, 2025 |
| K250283 | livanova usa | RAP Femoral Venous Cannulae | July 10, 2025 |
| K250610 | sorin group italia | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | June 27, 2025 |
| K251258 | medtronic | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | June 20, 2025 |
| K241248 | spectrum medical | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | May 31, 2024 |
| K240193 | sorin group italia | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R | February 22, 2024 |
| K233895 | edwards lifesciences | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZ | February 5, 2024 |
| K231206 | medtronic | DLP Silicone Coronary Artery Ostial Cannulae | December 7, 2023 |
| K230960 | medtronic | DLP Silicone Coronary Artery Ostial Cannulae | May 4, 2023 |
| K221353 | qura | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 2 | August 18, 2022 |
| K213540 | qura | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | May 20, 2022 |
| K203067 | qura | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula | November 8, 2021 |
| K212386 | angiodynamics | AngioVac F18 85 | September 30, 2021 |
| K201100 | medtronic | Bio-Medicus Life Support Catheter and Introducer | July 15, 2021 |
| K203057 | qura | Quantum Perfusion Arterial Cannula Graft | June 30, 2021 |