ALPHA MICRON 20 MICROAGGREGATE FILTER— 510(k) K955515

Substantially Equivalent

Alpha Therapeutic Corp.

FDA 510(k) clearance K955515 for ALPHA MICRON 20 MICROAGGREGATE FILTER, Substantially Equivalent on 1996-02-12. Applicant: Alpha Therapeutic Corp..

Clearance details

Applicant: Alpha Therapeutic Corp.
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1995-12-04
Decision date: 1996-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAK

product code CAK

Malfunction: 476
Total: 476

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.