DeviceClearance

Product code DYG— Cardiovascular

THERMAL DILUTION CATHETER

Classification name
Catheter, Flow Directed
Device class
Class 2
Regulation
21 CFR 870.1240
Advisory panel
Cardiovascular
Total cleared
99
First cleared
Most recent

Market context for product code DYG

FDA has cleared 99 devices under product code DYG between 1976 and 2024, filed by 54 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 DYG

Adverse events under product code DYG

product code DYG
Death
18
Malfunction
1,051
Other
1
Total
1,070

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 DYG

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