ESKA-HERRMANN TRACHEOSTOMY VALVE— 510(k) K871885

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K871885 for ESKA-HERRMANN TRACHEOSTOMY VALVE, Substantially Equivalent on 1987-06-08. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1987-05-14
Decision date: 1987-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray Hill, NJ, US

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Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

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.