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510(k) K962312

KEY CHAIN EMERGENCY AIRWAY by Ffrench Pocket Emergency Airway, Inc. — Product Code BWC

K962312 is an FDA 510(k) premarket notification submitted by Ffrench Pocket Emergency Airway, Inc. for the device "KEY CHAIN EMERGENCY AIRWAY". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1997
Date Received
June 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Emergency Airway
Device Class
Class II
Regulation Number
868.5090
Review Panel
AN
Submission Type

Other clearances for product code BWC

  • K200190 — ScalpelCric (October 30, 2020)
  • K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyr (February 17, 2017)
  • K153761 — Emergency Transtracheal Airway Catheter (September 22, 2016)
  • K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (November 6, 2013)
  • K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (May 26, 2005)
  • K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (December 20, 2001)
  • K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (October 9, 2001)
  • K952401 — ABELSON CRICOTHYROTOMY CANNULA (July 11, 1995)

FDA data resources