De Novo DEN240017

Device: ShortCut
Contact: hadas givon
De Novo number: DEN240017
Product code: SCZ
Regulation: 870.1254
Classification name: percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures
Decision: granted (DENG)
Decision date: 2024-09-27
Date received: 2024-04-17
Classification advisory: Cardiovascular
Review advisory: Cardiovascular
Type: Direct

Current FDA Classification#

Product code: SCZ
Device name: Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Medical specialty: Cardiovascular
Device class: 2
Regulation: 870.1254
Implant: N
Life sustain/support: N