SCZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1254
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| ShortCut (DEN240017) | Pi-Cardia, Ltd. | 2024-09-27 |
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