# K153530: Bridge Occlusion Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics, Inc.
- Decided: Feb 5, 2016 after 58 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021721 (2002). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140273: Equalizer Occlusion Balloon Catheter, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K183679: Occlusion Balloon Catheter (2019), 2 descendants of its own
- K251358: Bridge Plus Occlusion Balloon (590-002) (2025), 0 descendants of its own
- K210602: AortaSTAT Occlusion Device (2021), 0 descendants of its own
- K203540: Bridge Occlusion Balloon (2020), 0 descendants of its own

## Recalls of this device
- Mar 31, 2020 · Class II · Z-2143-2020: There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this ris
- Aug 7, 2017 · Class I · Z-3106-2017: Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

## Indications for use
The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.

Source page: https://510kreport.com/device/K153530
Methodology: https://510kreport.com/methodology