Product code DXL— Cardiovascular

SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT

Classification name: Injector, Indicator
Device class: Class 2
Regulation: 21 CFR 870.1660
Advisory panel: Cardiovascular
Total cleared: 3
First cleared: 1976-07-21
Most recent: 1976-09-03

Market context for product code DXL

FDA has cleared 3 devices under product code DXL, all in 1976, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code DXL

Instrumentation Laboratory CO2 clearances
Unimetrics Corp.1 clearance

Recent clearances under product code DXL

K760500 — TUBE, HEAVY GLASS WALL INJECTIONUnimetrics Corp.·1976-09-03
K760448 — SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECTInstrumentation Laboratory CO·1976-08-27
K760066 — TRAY, ICED INJECTABLE (26420)Instrumentation Laboratory CO·1976-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.