KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE— 510(k) K961977

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K961977 for KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE, Substantially Equivalent on 1996-07-31. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 1996-05-20
Decision date: 1996-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.