SCZ — Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Class II
Classification Details
- Product Code
- SCZ
- Device Class
- Class II
- Regulation Number
- 870.1254
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240017 | pi-cardia | ShortCut | September 27, 2024 |