DEN240017
- 510(k) number
- DEN240017
- Device name
- ShortCut
- Applicant
- Pi-Cardia, Ltd. IL
- Product code
- SCZ — Percutaneous Catheter For Cutting Or Splitting Heart
- Decision date
- 2024-09-27
- Date received
- 2024-04-17
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN240017
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.