Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
FDA product code SCZ · Class II (moderate risk) · 21 CFR 870.1254 · Cardiovascular
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.
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3213-2026 | Pi-Cardia Inc. ShortCut REF: Z-A-20.003-USTransfemoral catheter, positing arm may detached due to weld issue. | Pi Cardia Ltd | 07/06/2026Open, Classified |