THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM— 510(k) K973191

Substantially Equivalent

Pulmonx

FDA 510(k) clearance K973191 for THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM, Substantially Equivalent on 1998-02-13. Applicant: Pulmonx.

Clearance details

Applicant: Pulmonx
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1997-08-25
Decision date: 1998-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.