510(k) K120985— KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING

Substantially Equivalent

Kimberly-Clark Corp.

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2012-04-02
Decision date: 2012-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Roswell, GA, US

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.