K251358 is an FDA 510(k) clearance for the Bridge Plus Occlusion Balloon (590-002). This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Philips Image Guided Therapy Devices (Colorado Springs, US). The FDA issued a Cleared decision on June 24, 2025, 55 days after receiving the submission on April 30, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K251358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2025 |
| Decision Date | June 24, 2025 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJN - Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |