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510(k) K013241

Device
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
Applicant
Cook, Inc.
510(k) number
K013241
Product code
BWC
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-21
Date received
2001-09-28
Regulation
868.5090
Classification name
Needle, Emergency Airway
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
HEIDI MASTEN
Address
925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BWC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K153761Emergency Transtracheal Airway CatheterCook Incorporated2016-09-22
K130405RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SETTeleflex Medical2013-11-06
K050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KITSmiths Medical2005-05-26
K013252PATIL EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.2002-02-21
K013916MELKER EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.2001-12-20
K010016MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETERCook, Inc.2001-10-09
K962312KEY CHAIN EMERGENCY AIRWAYFfrench Pocket Emergency Airway, Inc.1997-06-17
K952401ABELSON CRICOTHYROTOMY CANNULAGilbert Surgical Instruments, Inc.1995-07-11
K85334531ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE31st. Centruy Medical Corp.1985-10-01
K790650WEISS EMERGENCY AIRWAY SYSTEMIntl. Medical Devices , Ltd.1979-06-27
K771587INSTANT AIRHyde, Vernon E., D.D.S.1977-09-02