TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).— 510(k) K955461

Substantially Equivalent

VBM Medizintechnik GmbH

FDA 510(k) clearance K955461 for TRANSTRACHEAL CATHETER (ACC. RAVUSSIN)., Substantially Equivalent on 1997-03-19. Applicant: VBM Medizintechnik GmbH.

Clearance details

Applicant: VBM Medizintechnik GmbH
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1995-11-29
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roy, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.