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510(k) DEN170055

Retrograde Intubation Set by Cook Incorporated — Product Code QCX

DEN170055 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Retrograde Intubation Set". The FDA issued a decision of De Novo Granted on December 12, 2018. The device falls under product code QCX (Retrograde Intubation Set), a Class II device regulated under 21 CFR 868.5095. Cook Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 12, 2018
Date Received
September 25, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retrograde Intubation Set
Device Class
Class II
Regulation Number
868.5095
Review Panel
AN
Submission Type

A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).

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)

FDA data resources