BRONCHO-CATH— 510(k) K771219

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K771219 for BRONCHO-CATH, Substantially Equivalent on 1977-08-04. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code BTS
Advisory panel: Anesthesiology
Date received: 1977-07-05
Decision date: 1977-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.