Syntheon LAA Exclusion System, Syntheon LAA Selection Guide— 510(k) K220305

Substantially Equivalent

Syntheon

FDA 510(k) clearance K220305 for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide, Substantially Equivalent on 2022-10-28. Applicant: Syntheon.

Clearance details

Applicant: Syntheon
Product code: Code PZX
Advisory panel: General, Plastic Surgery
Date received: 2022-02-02
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PZX

product code PZX

Death: 6
Total: 6

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.