FDA product code DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
DWF is the FDA product code for catheter, cannula and tubing, vascular, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4210 and reviewed by the Cardiovascular panel. FDA has cleared 401 510(k) submissions under DWF, 17 in the last five years, from 120 different applicants. The average 510(k) review took 111 days (median 83); 85 days on average over the last three years. FDA has posted 563 recalls for DWF devices, 41 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 152 |
| 2018 | 5 | 66 |
| 2019 | 3 | 138 |
| 2020 | 3 | 104 |
| 2021 | 5 | 305 |
| 2022 | 2 | 146 |
| 2023 | 2 | 126 |
| 2024 | 3 | 38 |
| 2025 | 4 | 92 |
| 2026 | 6 | 124 |
Compare with all 510(k) review times · Search every DWF clearance
Top DWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic, Inc. | 31 | 2026-04-23 |
| Dlp, Inc. | 22 | 1996-03-26 |
| 3M Health Care, Sarns | 21 | 1994-02-22 |
| Shiley, Inc. | 21 | 1990-04-10 |
| Edwards Lifesciences, LLC | 18 | 2020-03-29 |
115 more applicants have DWF clearances. See the full list in Caduvo.
Most recent DWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260195 | Medtronic, Inc. | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | 2026-04-23 | 91 |
| K250937 | LivaNova USA, Inc. | Venous Return Cannulae | 2026-03-11 | 348 |
| K260043 | Smart Reactors | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | 2026-02-23 | 47 |
| K253203 | Medtronic, Inc. | Retrograde Coronary Sinus Perfusion Cannulae | 2026-02-19 | 146 |
| K253671 | Sorin Group Italia S.R.L. | Dual Stage Venous Cannulae | 2026-01-30 | 70 |
Recalls for DWF devices
563 product recalls in 98 recall events; 41 initiated in the last five years and 42 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2017 | 11 |
| 2018 | 20 |
| 2019 | 186 |
| 2020 | 2 |
| 2021 | 28 |
| 2024 | 15 |
| 2025 | 4 |
| 2026 | 20 |
Frequently asked questions
What is FDA product code DWF?
DWF is the FDA product code for catheter, cannula and tubing, vascular, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4210 and reviewed by the Cardiovascular panel.
What device class is DWF?
Class II, regulation 21 CFR 870.4210. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWF?
Across 401 cleared submissions the average was 111 days from receipt to decision (median 83).
Which companies have the most DWF clearances?
Medtronic, Inc. (31); Dlp, Inc. (22); 3M Health Care, Sarns (21); Shiley, Inc. (21); Edwards Lifesciences, LLC (18).
Have DWF devices been recalled?
Yes: 563 product recalls across 98 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DWF
- Run a recall and safety report across every DWF manufacturer
- Watch product code DWF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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