510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTIClass II

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

21 CFR 880.5200 / General Hospital
FDA source (opens on fda.gov)

QTI is the FDA product code for Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QTI
Device name
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
FDA definition
Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QTI

By decision year
1 clearance under product code QTI with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTI by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTI
Applicants holding the most 510(k) clearances under product code QTI
ApplicantClearances
Becton Dickinson & Co1

Companies listing this code with FDA

Companies whose registered establishments list this code