DeviceClearance

K243860

Substantially Equivalent

AtriClip PRO-Mini LAA Exclusion System (PROM)

Applicant
AtriCure, Inc.
Product code
PZX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mason, OH, 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, 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.