MJN
- Product code
- MJN
- Device name
- Catheter, Intravascular Occluding, Temporary
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4450
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 90
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243795 | 2025-09-05 | Prytime Medical Devices, Inc. | pREBOA-PRO Catheter | FDA |
| K251358 | 2025-06-24 | Philips Image Guided Therapy Devices | Bridge Plus Occlusion Balloon (590-002) |
Official FDA classification page: MJN
Classification and pathway per current FDA publications. Data from openFDA (CC0).