510(k) DEN250033
- Device
- XplantR Explant Tool
- Applicant
- Hjarta Care, LLC
- 510(k) number
- DEN250033
- Product code
- SHR
- Decision
- Unknown (DENG)
- Decision date
- 2026-04-17
- Date received
- 2025-08-07
- Regulation
- 870.4520
- Classification name
- Device For Open Surgical Explant Of Endovascular Prostheses
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Brian Thorson
- Address
- N16 W23233 Stone Ridge Dr. Suite 200 Waukesha WI US 53188 53188
FDA Registration Numbers#
- 3017785723
Source Documents#
510(k) summary PDF not indicated by FDA