# DEN240017: ShortCut

- Pathway: De Novo (Direct)
- Applicant: Pi-Cardia, Ltd.
- Decided: Sep 27, 2024 after 163 days
- Product code: SCZ (Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures)
- Device class: 2
- Regulation: 21 CFR 870.1254
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252592: TELLTALE Electrosurgical Guidewire System (2025), 0 descendants of its own

## Indications for use
ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.

Source page: https://510kreport.com/device/DEN240017
Methodology: https://510kreport.com/methodology