DXL — Injector, Indicator Class II

FDA Device Classification

FDA product code DXL covers "Injector, Indicator", a Class II medical device regulated under 21 CFR 870.1660. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DXL
Device Class
Class II
Regulation Number
870.1660
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K760500unimetricsTUBE, HEAVY GLASS WALL INJECTIONSeptember 3, 1976
K760448instrumentation laboratorySYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECTAugust 27, 1976
K760066instrumentation laboratoryTRAY, ICED INJECTABLE (26420)July 21, 1976