PASSY-MUIR TRACH VALVE— 510(k) K851016

Substantially Equivalent

Passy & Passy, Inc.

FDA 510(k) clearance K851016 for PASSY-MUIR TRACH VALVE, Substantially Equivalent on 1985-06-07. Applicant: Passy & Passy, Inc..

Clearance details

Applicant: Passy & Passy, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1985-03-12
Decision date: 1985-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.