# K121219: Attain Clarity 6225 Venogram Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Sep 25, 2012 after 155 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822806 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012225: Attain 6215 Venogram Balloon Catheter, Medtronic Vascular (2001) Summary page 2.
- K081052: Occlusion Balloon Catheter, Model Venos, Oscor, Inc. (2008) Summary page 2.

## Indications for use
The Attain ClarityTm 6225 Venogram Balloon Catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.

Source page: https://510kreport.com/device/K121219
Methodology: https://510kreport.com/methodology