SSV PHONATE(TM) SHILEY SPEAKING VALVE— 510(k) K945406

Substantially Equivalent

Mallinckrodt Medical Tpi, Inc.

FDA 510(k) clearance K945406 for SSV PHONATE(TM) SHILEY SPEAKING VALVE, Substantially Equivalent on 1995-02-27. Applicant: Mallinckrodt Medical Tpi, Inc..

Clearance details

Applicant: Mallinckrodt Medical Tpi, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1994-11-03
Decision date: 1995-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.