21 CFR 870.5175 — Catheter, Septostomy
Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5175
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXF | Catheter, Septostomy | 2 | 20 | 3rd Party |
| QLZ | Septostomy Catheter, Reprocessed | 2 | 2 |
