EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE— 510(k) K870387

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K870387 for EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE, Substantially Equivalent on 1987-05-08. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1987-01-30
Decision date: 1987-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.