PSI-TEC ASPIRATOR— 510(k) K980392

Substantially Equivalent

Byron Medical

FDA 510(k) clearance K980392 for PSI-TEC ASPIRATOR, Substantially Equivalent on 1998-03-05. Applicant: Byron Medical.

Clearance details

Applicant: Byron Medical
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1998-02-02
Decision date: 1998-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.