Emergency Transtracheal Airway Catheter— 510(k) K153761

Name: FDA 510(k) clearance K153761
Creator: U.S. Food and Drug Administration
Published: 2016-09-22

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K153761 for Emergency Transtracheal Airway Catheter, Substantially Equivalent on 2016-09-22. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code BWC
Device class: Class 2
Regulation: 21 CFR 868.5090
Advisory panel: Anesthesiology
Date received: 2015-12-30
Decision date: 2016-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWC

view all

K200190 — ScalpelCric2020-10-30
K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set2017-02-17
K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET2013-11-06
K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT2005-05-26
K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET2002-02-21

More clearances from Cook Incorporated

view all

K233177 — Nest VT Vitrification Device2024-03-08
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K210734 — Endovascular Dilator and Sets2021-04-06
K203670 — Extra Large Check-Flo Introducer2021-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.