DeviceClearance

Product code OBJ— Cardiovascular

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Classification name
Catheter, Ultrasound, Intravascular
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Total cleared
79
First cleared
Most recent

FDA classification definition

“For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.”

— U.S. Food and Drug Administration, device classification record for product code OBJ under 21 CFR 870.1200, via openFDA

Market context for product code OBJ

FDA has cleared 79 devices under product code OBJ between 2003 and 2026, filed by 28 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 OBJ

Adverse events under product code OBJ

product code OBJ
Death
38
Injury
634
Malfunction
3,453
Total
4,125

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 OBJ

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