XplantR Explant Tool— 510(k) DEN250033
UnknownHjarta Care, LLC
FDA 510(k) clearance DEN250033 for XplantR Explant Tool, Unknown on 2026-04-17. Applicant: Hjarta Care, LLC. Device class: 2.
Clearance details
- Applicant
- Hjarta Care, LLC
- Product code
- Code SHR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4520
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Waukesha, WI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.