# K142692: Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Embolx, Inc.
- Decided: May 31, 2015 after 251 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: 6 generations back to K960806 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103780: Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon Catheter 6X9 MM; Micrus Summit Occlusio, Micrus Endovascular Corporation (2011) Summary page 4.

## Most influential descendants
- K180904: Sniper Infusion Catheter with Balloon Occlusion (2018), 0 descendants of its own

## Indications for use
The Embolx Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Embolx Occlusion Balloon Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.

Source page: https://510kreport.com/device/K142692
Methodology: https://510kreport.com/methodology