Clearance Summary
ShortCut received FDA 510(k) clearance under submission number DEN240017, sponsored by Pi-Cardia, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-09-27.
- Submission: DEN240017
- Applicant / Sponsor: Pi-Cardia, Ltd.
- Clearance pathway: Direct
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1254
- Decision date: 2024-09-27
Classification & Regulation
This clearance is catalogued under FDA product code SCZ and 21 CFR 870.1254, within the Cardiovascular review panel as a Class II device.