DXF · Class II · 21 CFR 870.5175

FDA Product Code DXF: Catheter, Septostomy

Leading manufacturers include NuMED, Inc. and Edwards Lifesciences, LLC.

2
Total
2
Cleared
58d
Avg days
2021
Since

List of Catheter, Septostomy devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
K221528
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910
NuMED, Inc.
Cardiovascular · 28d

How to use this database

This page lists all FDA 510(k) submissions for Catheter, Septostomy devices (product code DXF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →