TRUMPET VALVE— 510(k) K911415

Name: FDA 510(k) clearance K911415
Creator: U.S. Food and Drug Administration
Published: 1991-06-03

Substantially Equivalent

B. Braun of America, Inc.

FDA 510(k) clearance K911415 for TRUMPET VALVE, Substantially Equivalent on 1991-06-03. Applicant: B. Braun of America, Inc.. Device class: 2.

Clearance details

Applicant: B. Braun of America, Inc.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1991-04-01
Decision date: 1991-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.