Atlas FDA

Emergency Transtracheal Airway Catheter

FDA 510(k) clearance K153761 · decided 2016-09-22

Clearance details

K-number
K153761
Device name
Emergency Transtracheal Airway Catheter
Applicant
Cook Incorporated
Decision
Substantially Equivalent
Date received
2015-12-30
Decision date
2016-09-22
Days to decision
267 days
Clearance type
Traditional
Product code
BWC
Device class
2
Regulation number
868.5090
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Bloomington, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ScalpelCric (K200190)VBM Medizintechnik GmbH2020-10-30
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200)Cook Incorporated2017-02-17
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (K130405)Teleflex Medical2013-11-06
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166)Smiths Medical2005-05-26
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (K013241)Cook, Inc.2002-02-21
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (K013252)Cook, Inc.2002-02-21
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916)Cook, Inc.2001-12-20
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016)Cook, Inc.2001-10-09
KEY CHAIN EMERGENCY AIRWAY (K962312)Ffrench Pocket Emergency Airway, Inc.1997-06-17
ABELSON CRICOTHYROTOMY CANNULA (K952401)Gilbert Surgical Instruments, Inc.1995-07-11
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345)31st. Centruy Medical Corp.1985-10-01
WEISS EMERGENCY AIRWAY SYSTEM (K790650)Intl. Medical Devices , Ltd.1979-06-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005)Cook Incorporated2009-04-02
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006)Cook Incorporated2009-03-05
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004)Cook Incorporated2008-05-08
COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002)Cook Incorporated2000-06-12
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001)Cook Incorporated1998-07-08
COOK CHORIONIC VILLUS SAMPLING SET (P900007)Cook Incorporated1994-09-30