DeviceClearance

Product code DTK— Cardiovascular

SIMON NITINOL FILTER

Classification name
Filter, Intravascular, Cardiovascular
Device class
Class 2
Regulation
21 CFR 870.3375
Advisory panel
Cardiovascular
Total cleared
83
First cleared
Most recent

Market context for product code DTK

FDA has cleared 83 devices under product code DTK between 1976 and 2024, filed by 29 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 DTK

Adverse events under product code DTK

product code DTK
Death
208
Injury
11,286
Malfunction
3,002
Total
14,496

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 DTK

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