FDA Product Code
FDA Product Code SHR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4520
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250033 | XplantR Explant Tool | Hjarta Care, LLC | 2026-04-17 | Direct | — |
Product code SHR · Class II · Cardiovascular. Data: openFDA.