FDA 510(k) Applications for Medical Device Product Code "BWC"
(Needle, Emergency Airway)

FDA 510(k) Number Applicant Device Name Decision Date
K153761 COOK INCORPORATED Emergency Transtracheal Airway Catheter 09/22/2016
K160200 COOK INCORPORATED Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set 02/17/2017
K013241 COOK, INC. ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET 02/21/2002
K010016 COOK, INC. MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER 10/09/2001
K013916 COOK, INC. MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET 12/20/2001
K013252 COOK, INC. PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET 02/21/2002
K962312 FFRENCH POCKET EMERGENCY AIRWAY, INC. KEY CHAIN EMERGENCY AIRWAY 06/17/1997
K050166 SMITHS MEDICAL PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT 05/26/2005
K130405 TELEFLEX MEDICAL RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET 11/06/2013
K200190 VBM Medizintechnik GmbH ScalpelCric 10/30/2020


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