FDA product code MOF: Guide, Wire, Catheter, Neurovasculature
MOF is the FDA product code for guide, wire, catheter, neurovasculature. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Neurology panel. FDA has cleared 45 510(k) submissions under MOF, 23 in the last five years, from 20 different applicants. The average 510(k) review took 132 days (median 94); 185 days on average over the last three years. FDA has posted 2 recalls for MOF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class II |
| Regulation | 21 CFR 870.1330 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 30 |
| 2018 | 2 | 33 |
| 2019 | 4 | 58 |
| 2020 | 4 | 100 |
| 2022 | 1 | 90 |
| 2023 | 4 | 204 |
| 2024 | 2 | 230 |
| 2025 | 5 | 159 |
| 2026 | 11 | 167 |
Compare with all 510(k) review times · Search every MOF clearance
Top MOF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Asahi Intecc Co., Ltd. | 10 | 2026-02-02 |
| MicroVention, Inc. | 6 | 2020-07-02 |
| Arbor Endovascular, LLC | 5 | 2026-08-14 |
| Scientia Vascular, Inc. | 5 | 2026-08-06 |
| Scientia Vascular, LLC | 3 | 2023-03-10 |
15 more applicants have MOF clearances. See the full list in Caduvo.
Most recent MOF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254181 | Scientia Vascular | Aristotle 65 Macrowire | 2026-09-16 | 267 |
| K260751 | Piraeus Medical, Inc. | 35 Helix Guidewire | 2026-08-27 | 174 |
| K262424 | Arbor Endovascular, LLC | Willow 12 Guidewire | 2026-08-14 | 29 |
| K260223 | Scientia Vascular, Inc. | Aristotle Mini Guidewire | 2026-08-06 | 192 |
| K254006 | Rapid Medical Ltd. | Drivewire 35 Guidewire | 2026-07-17 | 214 |
Recalls for MOF devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code MOF?
MOF is the FDA product code for guide, wire, catheter, neurovasculature. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Neurology panel.
What device class is MOF?
Class II, regulation 21 CFR 870.1330. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOF?
Across 45 cleared submissions the average was 132 days from receipt to decision (median 94).
Which companies have the most MOF clearances?
Asahi Intecc Co., Ltd. (10); MicroVention, Inc. (6); Arbor Endovascular, LLC (5); Scientia Vascular, Inc. (5); Scientia Vascular, LLC (3).
Have MOF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-04-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MOF
- Run a recall and safety report across every MOF manufacturer
- Watch product code MOF 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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