DQI — Withdrawal/Infusion Pump Class II

FDA Device Classification

FDA product code DQI covers "Withdrawal/Infusion Pump", a Class II medical device regulated under 21 CFR 870.1800. Submissions are reviewed by the Cardiovascular panel. At least 9 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DQI
Device Class
Class II
Regulation Number
870.1800
Submission Type
Review Panel
HO
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K960486Karl Storz EndoscopyKSEA MODEL 383320 20 ANGIOMATOct 25, 1996
K935763W.O.M. World Of MedicineSURGIPUMPApr 21, 1994
K922541C.R. BardUSCI SUPER 9 PTCA GUIDING CATHETERDec 8, 1992
K924110LeocorLEOCOR CORFLO PUMP -- MODIFICATIONSep 1, 1992
K905189Baxter HealthcareBAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)Jan 30, 1991
K902444Intramed LaboratoriesCLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMPAug 30, 1990
K895688Nobles-Lai EngineeringNOBLES-LAI ENGINEERING INFUSION PUMPFeb 26, 1990
K895074Baxter HealthcareANGIOSCOPY PUMPJan 31, 1990
K871422OlympusOLYMPUS ANGIOSCOPY PUMPAug 12, 1987