FDA Product Code
FDA Product Code QJH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1342
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | 2025-09-10 | Special | PDF ↗ |
| DEN190038 | Surfacer Inside-Out Access Catheter System | Bluegrass Vascular Technologies, Inc. | 2020-02-10 | Direct | — |
Product code QJH · Class II · Cardiovascular. Data: openFDA.