DEN240017 is an FDA 510(k) submission for the ShortCut. This device is classified as a Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures (Class II - Special Controls, product code SCZ).
Submitted by Pi-Cardia, Ltd. (Rehovot, IL). The FDA issued a Not Cleared (DENG) decision on September 27, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1254. 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..
| 510(k) Number | DEN240017 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 17, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 163 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | SCZ - Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1254 |
| 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. |