Emergency Transtracheal Airway Catheter
FDA 510(k) K153761 · Cook Incorporated
510(k) numberK153761
Submission
- Device name
- Emergency Transtracheal Airway Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- December 30, 2015
- Decision date
- September 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWC – Needle, Emergency Airway
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5090
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200190 | ScalpelCricBWC · Traditional | VBM Medizintechnik GmbH | 10/30/2020SE |
| K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy…BWC · Traditional | Cook Incorporated | 02/17/2017SE |
| K130405 | Rusch Easycric Emergency Cricothyrotomy SetBWC · Traditional | Teleflex Medical | 11/06/2013SE |
| K050166 | Portex Emergency Cricothyroidotomy KitBWC · Traditional | Smiths Medical | 05/26/2005SE |
| K013252 | Patil Emergency Cricothyrotomy Catheter SetBWC · Traditional | Cook, Inc. | 02/21/2002SE |
| K013241 | Arndt Emergency Cricothyrotomy Catheter SetBWC · Traditional | Cook, Inc. | 02/21/2002SE |
| K013916 | Melker Emergency Cricothyrotomy Catheter SetBWC · Traditional | Cook, Inc. | 12/20/2001SE |
| K010016 | Melker Cuffed Emergency Cricothyrotomy CatheterBWC · Traditional | Cook, Inc. | 10/09/2001SE |
| K962312 | Key Chain Emergency AirwayBWC · Traditional | Ffrench Pocket Emergency Airway, Inc. | 06/17/1997SE |
| K952401 | Abelson Cricothyrotomy CannulaBWC · Traditional | Gilbert Surgical Instruments, Inc. | 07/11/1995SE |
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| K223098 | Bakri Essential Postpartum BalloonOQY · Special | 10/28/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
Questions and answers
When was Emergency Transtracheal Airway Catheter cleared by the FDA?
Emergency Transtracheal Airway Catheter (K153761) received a 510(k) decision of Substantially Equivalent on September 22, 2016, 267 days after the submission was received.
What is the product code of K153761?
The FDA product code is BWC – Needle, Emergency Airway, a Class II (moderate risk) device regulated under 21 CFR 868.5090.