ShortCut— 510(k) DEN240017

Unknown

Pi-Cardia, Ltd.

FDA 510(k) clearance DEN240017 for ShortCut, Unknown on 2024-09-27. Applicant: Pi-Cardia, Ltd..

Clearance details

Applicant: Pi-Cardia, Ltd.
Product code: Code SCZ
Advisory panel: Cardiovascular
Date received: 2024-04-17
Decision date: 2024-09-27
Decision: Unknown
Clearance type: Direct
Location: Rehovot, IL

View on FDA.gov ↗

Adverse events under product code SCZ

product code SCZ

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.