XplantR Explant Tool
FDA 510(k) clearance DEN250033 · decided 2026-04-17
Clearance details
- K-number
- DEN250033
- Device name
- XplantR Explant Tool
- Applicant
- Hjarta Care, LLC
- Decision
- Unknown
- Date received
- 2025-08-07
- Decision date
- 2026-04-17
- Days to decision
- 253 days
- Clearance type
- Direct
- Product code
- SHR
- Device class
- 2
- Regulation number
- 870.4520
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.