SOFTECH PLUS ETC02 CANNULA— 510(k) K132946

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K132946 for SOFTECH PLUS ETC02 CANNULA, Substantially Equivalent on 2014-06-04. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2013-09-19
Decision date: 2014-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.