SIMS BLUE LINE ENDOBRONCHIAL TUBE— 510(k) K953483

Substantially Equivalent

Smiths Industries Medical Systems, Inc.

FDA 510(k) clearance K953483 for SIMS BLUE LINE ENDOBRONCHIAL TUBE, Substantially Equivalent on 1995-10-24. Applicant: Smiths Industries Medical Systems, Inc..

Clearance details

Applicant: Smiths Industries Medical Systems, Inc.
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 1995-07-25
Decision date: 1995-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.