FAST TRACT TRANSTRACHEAL PROCEDURE KIT— 510(k) K970018

Substantially Equivalent

L.W. Ward and Assoc., Inc.

FDA 510(k) clearance K970018 for FAST TRACT TRANSTRACHEAL PROCEDURE KIT, Substantially Equivalent on 1997-03-28. Applicant: L.W. Ward and Assoc., Inc..

Clearance details

Applicant: L.W. Ward and Assoc., Inc.
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 1997-01-02
Decision date: 1997-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

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.