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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K251358
Device Name Bridge Plus Occlusion Balloon (590-002)
Applicant
Philips Image Guided Therapy Devices
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Sondra Chandler
Correspondent
Philips Image Guided Therapy Devices
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Sondra Chandler
Regulation Number870.4450
Classification Product Code
MJN  
Date Received04/30/2025
Decision Date 06/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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