Bridge Plus Occlusion Balloon (590-002)— 510(k) K251358

Substantially Equivalent

Philips Image Guided Therapy Devices

FDA 510(k) clearance K251358 for Bridge Plus Occlusion Balloon (590-002), Substantially Equivalent on 2025-06-24. Applicant: Philips Image Guided Therapy Devices.

Clearance details

Applicant: Philips Image Guided Therapy Devices
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2025-04-30
Decision date: 2025-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.