FDA product code MCW: Catheter, Peripheral, Atherectomy
MCW is the FDA product code for catheter, peripheral, atherectomy. It is a Class II device, regulated under 21 CFR 870.4875 and reviewed by the Cardiovascular panel. FDA has cleared 146 510(k) submissions under MCW, 17 in the last five years, from 49 different applicants. The average 510(k) review took 102 days (median 76); 68 days on average over the last three years. FDA has posted 34 recalls for MCW devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Peripheral, Atherectomy |
| Device class | Class II |
| Regulation | 21 CFR 870.4875 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MCW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 90 |
| 2018 | 8 | 113 |
| 2019 | 3 | 148 |
| 2020 | 2 | 58 |
| 2021 | 6 | 110 |
| 2022 | 6 | 109 |
| 2023 | 4 | 98 |
| 2024 | 3 | 60 |
| 2025 | 3 | 72 |
| 2026 | 1 | 73 |
Compare with all 510(k) review times · Search every MCW clearance
Top MCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiovascular Systems, Inc. | 19 | 2022-03-01 |
| Pathway Medical Technologies, Inc. | 16 | 2012-02-24 |
| Avinger, Inc. | 10 | 2023-06-06 |
| Eximo Medical, Ltd. | 7 | 2024-06-27 |
| Spectranetics, Inc. | 6 | 2022-12-08 |
44 more applicants have MCW clearances. See the full list in Caduvo.
Most recent MCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260244 | Eximo Medical | Auryon Atherectomy System | 2026-04-10 | 73 |
| K250723 | Cardio Flow Inc., | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | 2025-04-25 | 46 |
| K250385 | Spectranetics | Turbo-Elite Laser Atherectomy Catheter | 2025-03-13 | 30 |
| K242757 | Bard Peripheral Vascular, Inc. | Rotarex Atherectomy System | 2025-01-30 | 140 |
| K242947 | Cardio Flow Inc., | FreedomFlow Orbital Circumferential Atherectomy System | 2024-11-05 | 41 |
Recalls for MCW devices
34 product recalls in 29 recall events; 8 initiated in the last five years and 4 still open. Most recent: 2025-02-05.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 1 |
| 2021 | 4 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MCW?
MCW is the FDA product code for catheter, peripheral, atherectomy. It is a Class II device, regulated under 21 CFR 870.4875 and reviewed by the Cardiovascular panel.
What device class is MCW?
Class II, regulation 21 CFR 870.4875. Typical premarket route: 510(k).
How long does a 510(k) take for product code MCW?
Across 146 cleared submissions the average was 102 days from receipt to decision (median 76).
Which companies have the most MCW clearances?
Cardiovascular Systems, Inc. (19); Pathway Medical Technologies, Inc. (16); Avinger, Inc. (10); Eximo Medical, Ltd. (7); Spectranetics, Inc. (6).
Have MCW devices been recalled?
Yes: 34 product recalls across 29 recall events; the most recent began 2025-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MCW
- Run a recall and safety report across every MCW manufacturer
- Watch product code MCW 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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