# K012225: Attain 6215 Venogram Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 28, 2001 after 43 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
Longest line of descent: 1 generation back to K822806 (1982). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822806: Balloon Wedge Pressure, Angiographic, Nova Medical Specialties (1982) Summary page 2.
- K900677: Accent DG (TM) Balloon Angioplasty Catheter, Cook, Inc. (1991) Summary page 2.
- K973298: Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter, Cardima, Inc. (1998) Summary page 2.

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

## Indications for use
The Attain 6215 Venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.

Source page: https://510kreport.com/device/K012225
Methodology: https://510kreport.com/methodology