Cleared Traditional

Bridge Plus Occlusion Balloon (590-002)

K251358 · Philips Image Guided Therapy Devices · Cardiovascular
Jun 2025
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K251358 is an FDA 510(k) clearance for the Bridge Plus Occlusion Balloon (590-002), 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 review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K251358 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MJN — Catheter, Intravascular Occluding, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450