FDA Product Code
FDA Product Code QEK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1415
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192442 | FFRangio | Cathworks, Ltd. | 2019-12-09 | Special | PDF ↗ |
| K182149 | FFRangio System | Cathworks, Ltd. | 2018-12-19 | Traditional | PDF ↗ |
Product code QEK · Class II · Cardiovascular. Data: openFDA.