NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
Device Facts
| Record ID | K001804 |
|---|---|
| Device Name | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER |
| Applicant | NuMED, Inc. |
| Product Code | DXF · Cardiovascular |
| Decision Date | Jul 12, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.5175 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.
