510(k) K251358

Bridge Plus Occlusion Balloon (590-002) by Philips Image Guided Therapy Devices — Product Code MJN

K251358 is an FDA 510(k) premarket notification submitted by Philips Image Guided Therapy Devices for the device "Bridge Plus Occlusion Balloon (590-002)". The FDA issued a decision of Substantially Equivalent on June 24, 2025. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450.