DWF
- Product code
- DWF
- Device name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4210
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 401
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260195 | 2026-04-23 | Medtronic, Inc. | Elongated One-Piece Arterial (EOPA) 3D Arterial Can | |
| K250937 | 2026-03-11 | LivaNova USA, Inc. | Venous Return Cannulae | |
| K260043 | 2026-02-23 | Smart Reactors | Smart Reactors Camouflage Coated Extracorporeal Card | |
| K253203 | 2026-02-19 | Medtronic, Inc. | Retrograde Coronary Sinus Perfusion Cannulae | |
| K253671 | 2026-01-30 | Sorin Group Italia S.R.L. | Dual Stage Venous Cannulae | |
| K253998 | 2026-01-20 | Medtronic, Inc. | Clearview Intracoronary Shunts | |
| K253106 | 2025-10-24 | AngioDynamics, Inc. | AngioVac Cannula | |
| K250283 | 2025-07-10 | LivaNova USA, Inc. | RAP Femoral Venous Cannulae | |
| K250610 | 2025-06-27 | Sorin Group Italia S.R.L. | Easyflow (103-200; 103-300); Easyflow Duo (103-210; | |
| K251258 | 2025-06-20 | Medtronic, Inc. | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Ven | |
| K241248 | 2024-05-31 | Spectrum Medical S.R.L. | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V | |
| K240193 | 2024-02-22 | Sorin Group Italia S.R.L. | R501 - R502 aortic root cannulae with and without ve | |
| K233895 | 2024-02-05 | Edwards Lifesciences | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, | FDA |
| K231206 | 2023-12-07 | Medtronic, Inc. | DLP Silicone Coronary Artery Ostial Cannulae |
Official FDA classification page: DWF
Classification and pathway per current FDA publications. Data from openFDA (CC0).