510(k) DEN240017

ShortCut by Pi-Cardia, Ltd. — Product Code SCZ

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.