510(k) DEN240017
DEN240017 is an FDA 510(k) premarket notification submitted by Pi-Cardia, Ltd. for the device "ShortCut". The FDA issued a decision of De Novo Granted on September 27, 2024. The device falls under product code SCZ (Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures), a Class II device regulated under 21 CFR 870.1254.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 27, 2024
- Date Received
- April 17, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Device Class
- Class II
- Regulation Number
- 870.1254
- Review Panel
- CV
- Submission Type
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.