Home / 510(k) Clearances / K153761

510(k) K153761

Emergency Transtracheal Airway Catheter by Cook Incorporated — Product Code BWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2016
Date Received
December 30, 2015
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 by Cook Incorporated

  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)
  • K203670 — Extra Large Check-Flo Introducer (February 16, 2021)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K191163 — Lumax Guiding Catheter (December 12, 2019)
  • K190084 — McLean-Ring Enteral Feeding Tube Set (October 11, 2019)

Other clearances for product code BWC

  • K200190 — ScalpelCric (October 30, 2020)
  • K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyr (February 17, 2017)
  • K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (November 6, 2013)
  • K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (May 26, 2005)
  • K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013241 — ARNDT 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)
  • K962312 — KEY CHAIN EMERGENCY AIRWAY (June 17, 1997)
  • K952401 — ABELSON CRICOTHYROTOMY CANNULA (July 11, 1995)