Class Class II
Bridge Plus Occlusion Balloon (590-002) (K251358)
Description
Bridge Plus Occlusion Balloon (590-002) by Philips Image Guided Therapy Devices, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251358
Clearance Date2025-06-24
Clearance TypeTraditional
Product CodeMJN
Regulation Number870.4450
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251358
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Bridge Plus Occlusion Balloon (590-002) (K251358) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019 |
| K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016 |
Trace the full predicate network for K251358
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.