# K180904: Sniper Infusion Catheter with Balloon Occlusion

- Pathway: 510(k) (Traditional)
- Applicant: Embolx, Inc.
- Decided: Jun 8, 2018 after 63 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: 7 generations back to K960806 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142692: Occlusion Balloon Catheter, Embolx, Inc. (2015) Summary page 4.

## Indications for use
Sniper Infusion Catheter with Balloon Occlusion is intended for use in the blood vessels of the peripheral vasculature where temporary occlusion is desired and offers vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Sniper Infusion Catheter with Balloon Occlusion 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/K180904
Methodology: https://510kreport.com/methodology