FDA 510(k)

Bridge Plus Occlusion Balloon (590-002)

Numéro K : K251358 · 2025-06-24

DemandeurPhilips Image Guided Therapy Devices

Date de décision2025-06-24

Code produitMJN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Bridge Plus Occlusion Balloon (590-002) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Devices. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K251358. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Bridge Plus Occlusion Balloon (590-002)?

Bridge Plus Occlusion Balloon (590-002) is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Philips Image Guided Therapy Devices. The 510(k) number is K251358.

When did Bridge Plus Occlusion Balloon (590-002) receive FDA 510(k) clearance?

Bridge Plus Occlusion Balloon (590-002) received FDA 510(k) clearance on 2025-06-24, under 510(k) number K251358.

Who is the listed applicant for Bridge Plus Occlusion Balloon (590-002)?

The FDA 510(k) record lists Philips Image Guided Therapy Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bridge Plus Occlusion Balloon (590-002)?

The FDA product code for Bridge Plus Occlusion Balloon (590-002) is MJN.

Essais cliniques associés

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Dispositifs connexes (Code : MJN)

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC K212324RenovoCathRenovorx, Inc.K210602AortaSTAT Occlusion DeviceRenalpro Medical, Inc.

Source officielle

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