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QCXClass II

Retrograde Intubation Set

21 CFR 868.5095 / Anesthesiology
FDA source (opens on fda.gov)

QCX is the FDA product code for Retrograde Intubation Set, a class II device type, regulated under 21 CFR 868.5095. FDA's definition for this code reads: "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)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QCX
Device name
Retrograde Intubation Set
FDA 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).
Regulation
21 CFR 868.5095
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code QCX

By decision year
1 clearance under product code QCX with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QCX by decision year
YearClearances
20181

Applicants with the most clearances

Product code QCX
Applicants holding the most 510(k) clearances under product code QCX
ApplicantClearances
Cook Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code