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

Name: FDA 510(k) clearance K251358
Creator: U.S. Food and Drug Administration
Published: 2025-06-24

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. Device class: 2.

Clearance details

Applicant: Philips Image Guided Therapy Devices
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
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 ↗

Recent devices under product code MJN

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K243795 — pREBOA-PRO Catheter2025-09-05
K221294 — preCARDIA Occlusion System2023-06-30
K214060 — LANDMARK REBOA Catheter2022-09-19
K211610 — Fogarty Occlusion Catheter2022-02-14
K212324 — RenovoCath2021-08-23

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.