Atlas FDA

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

FDA 510(k) clearance K050166 · decided 2005-05-26

Clearance details

K-number
K050166
Device name
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
Applicant
Smiths Medical
Decision
Substantially Equivalent
Date received
2005-01-26
Decision date
2005-05-26
Days to decision
120 days
Clearance type
Traditional
Product code
BWC
Device class
2
Regulation number
868.5090
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Hythe, Kent, GB
Third-party review
No
Expedited review
No

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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
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Recalls involving this device

No recalls on record reference this clearance.