FDA Product Code
FDA Product Code QLZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5175
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213584 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | 2023-04-04 | Traditional | PDF ↗ |
| K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | 2020-07-30 | Traditional | PDF ↗ |
Product code QLZ · Class II · Cardiovascular. Data: openFDA.