# K133750: Occluder Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jan 8, 2014 after 30 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K841941 (1984). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841941: Van-Tec Occlusion Balloon Catheter, Van-Tec, Inc. (1984) Summary page 1.

## Most influential descendants
- K183323: UPJ Occlusion Balloon Catheter (2019), 0 descendants of its own

## Indications for use
The Occluder Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.

Source page: https://510kreport.com/device/K133750
Methodology: https://510kreport.com/methodology
