DeviceClearance

Product code DYB— Cardiovascular

CATHETER INTRODUCER

Classification name
Introducer, Catheter
Device class
Class 2
Regulation
21 CFR 870.1340
Advisory panel
Cardiovascular
Total cleared
706
First cleared
Most recent

Market context for product code DYB

FDA has cleared 706 devices under product code DYB between 1977 and 2026, filed by 263 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 DYB

Adverse events under product code DYB

product code DYB
Death
808
Injury
5,922
Malfunction
16,516
Other
5
Total
23,251

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 DYB

1–100 of 706

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