RUSCH ENDOBRONCHIAL TUBE SETS— 510(k) K951091

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K951091 for RUSCH ENDOBRONCHIAL TUBE SETS, Substantially Equivalent on 1995-06-08. Applicant: Rusch Intl..

Clearance details

Applicant: Rusch Intl.
Product code: Code BTS
Advisory panel: Anesthesiology
Date received: 1995-03-09
Decision date: 1995-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

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Adverse events under product code BTS

product code BTS

Death: 2
Malfunction: 877
Total: 879

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.