DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class II
FDA product code DWF covers "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4210. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260195 | medtronic | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | April 23, 2026 |
| 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 |