DeviceClearance

Product code DRE— Cardiovascular

VESSEL DILATOR

Classification name
Dilator, Vessel, For Percutaneous Catheterization
Device class
Class 2
Regulation
21 CFR 870.1310
Advisory panel
Cardiovascular
Total cleared
105
First cleared
Most recent

Market context for product code DRE

FDA has cleared 105 devices under product code DRE between 1976 and 2026, filed by 68 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 DRE

Adverse events under product code DRE

product code DRE
Death
100
Injury
832
Malfunction
597
Other
3
Total
1,532

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 DRE

1–100 of 105

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