QLZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Septostomy Catheter, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5175
- Medical specialty
- Cardiovascular
- Flags
- GMP exempt
- FDA definition
- To create or enlarge an atrial septal defect in the heart.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Reprocessed NRG Transseptal Needle (K213584) | Innovative Health, LLC | 2023-04-04 | + Add |
| Reprocessed NRG Transseptal Needle (K200060) | Innovative Health, LLC | 2020-07-30 | + Add |
Track QLZ automatically
Every clearance here is in the API, with alerts when new ones post.