FDA Product Code SCZ: Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
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.
Leading manufacturers include Pi-Cardia, Ltd..
1
Total
0
Cleared
163d
Avg days
2024
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Devices (Product Code SCZ)
1 devices
About Product Code SCZ - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SCZ since 2024, with 0 receiving FDA clearance (average review time: 163 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.