TRACHEOSTOMY CLEANING TRAY— 510(k) K840664

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K840664 for TRACHEOSTOMY CLEANING TRAY, Substantially Equivalent on 1984-03-12. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1984-02-15
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.