Neonatal ConchaSmart Breathing Circuits— 510(k) K173280

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K173280 for Neonatal ConchaSmart Breathing Circuits, Substantially Equivalent on 2018-08-02. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2017-10-16
Decision date: 2018-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.