DeviceClearance

K885137

Substantially Equivalent

ASTRO TRACE (MODEL AT-02)

Applicant
The LE Blanc Corp.
Product code
DSA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Augusta, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA
Death
2
Total
2

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.