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.
Summary
Hjarta Care's XplantR Explant Tool is filed under product code SHR (Device For Open Surgical Explant Of Endovascular Prostheses). The record doesn't describe the tool beyond its name and that code name.
Class II, 21 CFR 870.4520. Cardiovascular is both the classification panel and the review panel. The record lists the submission type as Direct.
Hjarta Care filed from Waukesha, Wisconsin. Review took 253 calendar days (August 7, 2025 to April 17, 2026).
Clearance details
- Applicant
- Hjarta Care, LLC
- Product code
- Product 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.