# K221528: Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 22, 2022 after 88 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fogarty Dilation Catheter for Atrial Septostomy, Model 83-05-05F: named in the summary without a submission number

## Indications for use
The Fogarty dilation atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber. The Miller balloon atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.

Source page: https://510kreport.com/device/K221528
Methodology: https://510kreport.com/methodology