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

FDA 510(k) Number Applicant Device Name Decision Date
K853345 31ST. CENTRUY MEDICAL CORP. 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE 10/01/1985
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
K952401 GILBERT SURGICAL INSTRUMENTS, INC. ABELSON CRICOTHYROTOMY CANNULA 07/11/1995
K771587 HYDE, VERNON E., D.D.S. INSTANT AIR 09/02/1977
K790650 INTL. MEDICAL DEVICES LTD. WEISS EMERGENCY AIRWAY SYSTEM 06/27/1979
K050166 SMITHS MEDICAL PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT 05/26/2005
K130405 TELEFLEX MEDICAL RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET 11/06/2013


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