ASTRO TRACE (MODEL AT-01)— 510(k) K884592

Substantially Equivalent

The LE Blanc Corp.

FDA 510(k) clearance K884592 for ASTRO TRACE (MODEL AT-01), Substantially Equivalent on 1989-03-02. Applicant: The LE Blanc Corp..

Clearance details

Applicant: The LE Blanc Corp.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1988-11-03
Decision date: 1989-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.