# K081052: Occlusion Balloon Catheter, Model Venos

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Jun 18, 2008 after 65 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121219: Attain Clarity 6225 Venogram Balloon Catheter (2012), 0 descendants of its own

## Indications for use
The Occlusion Balloon Catheter, model Venos TM, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.

Source page: https://510kreport.com/device/K081052
Methodology: https://510kreport.com/methodology