# K183679: Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Qxmedical, LLC
- Decided: Apr 24, 2019 after 117 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.
2 later devices descend from it; 2 cite it directly.
1 of 6 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.

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

## Indications for use
The Occlusion Balloon Catheter is indicated for temporary occlusion of large vessels, including the superior vena cava, in applications including perioperative occlusion and emergency control of hemorrhage.

Source page: https://510kreport.com/device/K183679
Methodology: https://510kreport.com/methodology