# K203540: Bridge Occlusion Balloon

- Pathway: 510(k) (Special)
- Applicant: Spectranetics, Inc.
- Decided: Dec 23, 2020 after 20 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: 3 generations back to K021721 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153530: Bridge Occlusion Balloon, Spectranetics, Inc. (2016) Summary page 4.

## 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/K203540
Methodology: https://510kreport.com/methodology