# K251358: Bridge Plus Occlusion Balloon (590-002)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Image Guided Therapy Devices
- Decided: Jun 24, 2025 after 55 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021721 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183679: Occlusion Balloon Catheter, Qxmedical, LLC (2019) Summary page 5.
- K153530: Bridge Occlusion Balloon, Spectranetics, Inc. (2016) Summary page 5.

## Indications for use
The Bridge Plus Occlusion Balloon catheter is is indicated for temporary vessel occlusion of the Superior Vena Cava (SVC) and Inferior Vena Cava (SVC) in applications including perioperative occlusion and emergency control of hemorrhage.

Source page: https://510kreport.com/device/K251358
Methodology: https://510kreport.com/methodology