DeviceClearance

Product code DRA— Cardiovascular

CRI CYNOSAR CATHETER

Classification name
Catheter, Steerable
Device class
Class 2
Regulation
21 CFR 870.1280
Advisory panel
Cardiovascular
Total cleared
42
First cleared
Most recent

Market context for product code DRA

FDA has cleared 42 devices under product code DRA between 1984 and 2026, filed by 22 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 DRA

Adverse events under product code DRA

product code DRA
Death
156
Injury
3,133
Malfunction
6,266
Total
9,555

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 DRA

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