FDA product code MJN: Catheter, Intravascular Occluding, Temporary
MJN is the FDA product code for catheter, intravascular occluding, temporary. It is a Class II device, regulated under 21 CFR 870.4450 and reviewed by the Cardiovascular panel. FDA has cleared 90 510(k) submissions under MJN, 5 in the last five years, from 45 different applicants. The average 510(k) review took 133 days (median 106); 162 days on average over the last three years. FDA has posted 21 recalls for MJN devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intravascular Occluding, Temporary |
| Device class | Class II |
| Regulation | 21 CFR 870.4450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MJN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 175 |
| 2018 | 3 | 84 |
| 2019 | 3 | 116 |
| 2020 | 4 | 89 |
| 2021 | 4 | 127 |
| 2022 | 2 | 266 |
| 2023 | 1 | 422 |
| 2025 | 2 | 162 |
Compare with all 510(k) review times · Search every MJN clearance
Top MJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| LeMaitre Vascular, Inc. | 8 | 2016-01-21 |
| Micro Therapeutics, Inc. | 7 | 2002-06-18 |
| Prytime Medical Devices, Inc. | 5 | 2025-09-05 |
| NuMED, Inc. | 5 | 2016-06-20 |
| Renovorx, Inc. | 4 | 2021-08-23 |
40 more applicants have MJN clearances. See the full list in Caduvo.
Most recent MJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243795 | Prytime Medical Devices, Inc. | pREBOA-PRO Catheter | 2025-09-05 | 269 |
| K251358 | Philips Image Guided Therapy Devices | Bridge Plus Occlusion Balloon (590-002) | 2025-06-24 | 55 |
| K221294 | Abiomed, Inc. | preCARDIA Occlusion System | 2023-06-30 | 422 |
| K214060 | Zien Medical Technologies, Inc. | LANDMARK REBOA Catheter | 2022-09-19 | 266 |
| K211610 | Edwards Lifesciences, LLC | Fogarty Occlusion Catheter | 2022-02-14 | 265 |
Recalls for MJN devices
21 product recalls in 14 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-07-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code MJN?
MJN is the FDA product code for catheter, intravascular occluding, temporary. It is a Class II device, regulated under 21 CFR 870.4450 and reviewed by the Cardiovascular panel.
What device class is MJN?
Class II, regulation 21 CFR 870.4450. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJN?
Across 90 cleared submissions the average was 133 days from receipt to decision (median 106).
Which companies have the most MJN clearances?
LeMaitre Vascular, Inc. (8); Micro Therapeutics, Inc. (7); Prytime Medical Devices, Inc. (5); NuMED, Inc. (5); Renovorx, Inc. (4).
Have MJN devices been recalled?
Yes: 21 product recalls across 14 recall events; the most recent began 2021-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MJN
- Run a recall and safety report across every MJN manufacturer
- Watch product code MJN 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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