RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET— 510(k) K133173

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K133173 for RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET, Substantially Equivalent on 2014-05-23. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2013-10-17
Decision date: 2014-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.