DeviceClearance

Product code DSY— Cardiovascular

DIASTAT VASCULAR ACCESS GRAFT

Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class
Class 2
Regulation
21 CFR 870.3450
Advisory panel
Cardiovascular
Total cleared
188
First cleared
Most recent

Market context for product code DSY

FDA has cleared 188 devices under product code DSY between 1976 and 2026, filed by 53 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 DSY

Adverse events under product code DSY

product code DSY
Death
29
Injury
694
Total
723

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 DSY

1–100 of 188

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