SHR — Device For Open Surgical Explant Of Endovascular Prostheses Class II
FDA product code SHR covers "Device For Open Surgical Explant Of Endovascular Prostheses", a Class II medical device regulated under 21 CFR 870.4520. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHR
- Device Class
- Class II
- Regulation Number
- 870.4520
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250033 | Hjarta Care | XplantR Explant Tool | Apr 17, 2026 |