DeviceClearance

Product code DXT— Cardiovascular

Sterile High-pressure Angiographic Syringes for Single-use

Classification name
Injector And Syringe, Angiographic
Device class
Class 2
Regulation
21 CFR 870.1650
Advisory panel
Cardiovascular
Total cleared
210
First cleared
Most recent

Market context for product code DXT

FDA has cleared 210 devices under product code DXT between 1978 and 2026, filed by 88 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.

Clearances per year

last 15 years

Top applicants under product code DXT

Adverse events under product code DXT

product code DXT
Death
39
Injury
242
Malfunction
463
Other
3
Total
747

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DXT

1–100 of 210

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