Product code QCX

Device name: Retrograde Intubation Set
Medical specialty: Anesthesiology
Device class: 2
Regulation number: 868.5095
Review panel: AN
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Ineligible
Definition: 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).
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN170055	Retrograde Intubation Set	Cook Incorporated	2018-12-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00827002576124	Cook	COOK INCORPORATED	2019-11-26
00827002576131	Cook	COOK INCORPORATED	2019-11-26
00827002576148	Cook	COOK INCORPORATED	2019-11-26

Related 510(k) Records#