FDA product code QLZ: Septostomy Catheter, Reprocessed
QLZ is the FDA product code for septostomy catheter, reprocessed. It is a Class II device, regulated under 21 CFR 870.5175 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under QLZ, 1 in the last five years. The average 510(k) review took 354 days (median 354).
Definition
To create or enlarge an atrial septal defect in the heart.
Classification
| Field | Value |
|---|---|
| Device name | Septostomy Catheter, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.5175 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| GMP exempt | Yes |
510(k) clearances per year for QLZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 199 |
| 2023 | 1 | 508 |
Compare with all 510(k) review times · Search every QLZ clearance
Top QLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 2 | 2023-04-04 |
Most recent QLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213584 | Innovative Health, LLC | Reprocessed NRG Transseptal Needle | 2023-04-04 | 508 |
| K200060 | Innovative Health, LLC | Reprocessed NRG Transseptal Needle | 2020-07-30 | 199 |
Recalls for QLZ devices
openFDA lists no recalls for product code QLZ.
Frequently asked questions
What is FDA product code QLZ?
QLZ is the FDA product code for septostomy catheter, reprocessed. It is a Class II device, regulated under 21 CFR 870.5175 and reviewed by the Cardiovascular panel.
What device class is QLZ?
Class II, regulation 21 CFR 870.5175. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLZ?
Across 2 cleared submissions the average was 354 days from receipt to decision (median 354).
Which companies have the most QLZ clearances?
Innovative Health, LLC (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QLZ
- Run a recall and safety report across every QLZ manufacturer
- Watch product code QLZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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