Device type
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Product code SCZ · Class II · 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.
Recent 510(k)s
No 510(k) clearances in the archive for SCZ.
Recent recalls
Sep 23, 2026
Z-3213-2026
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD
- SCZ
- Class II
- Ongoing