DeviceClearance

LAA Exclusion System— 510(k) K232295

Substantially Equivalent

Syntheon, LLC

FDA 510(k) clearance K232295 for LAA Exclusion System, Substantially Equivalent on 2023-08-30. Applicant: Syntheon, LLC.

Clearance details

Applicant
Syntheon, LLC
Product code
Code PZX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code PZX

product code PZX
Death
6
Total
6

Source: openFDA MAUDE database, through . 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.