QLZ · Septostomy Catheter, Reprocessed
Cardiovascular · 21 CFR 870.5175 · Class 2
Overview
| Product Code | QLZ |
|---|---|
| Device Name | Septostomy Catheter, Reprocessed |
| Regulation | 21 CFR 870.5175 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| GMP Exempt | Yes |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213584 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | Apr 4, 2023 | SESE |
| K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | Jul 30, 2020 | SESE |
Top Applicants
- Innovative Health, LLC — 2 clearances
