DeviceClearance

Product code DXC— Cardiovascular

HEARTPORT ENDOAORTIC CLAMP

Classification name
Clamp, Vascular
Device class
Class 2
Regulation
21 CFR 870.4450
Advisory panel
Cardiovascular
Total cleared
205
First cleared
Most recent

Market context for product code DXC

FDA has cleared 205 devices under product code DXC between 1976 and 2026, filed by 127 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 DXC

Adverse events under product code DXC

product code DXC
Death
14
Injury
442
Malfunction
2,209
Other
1
Total
2,666

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 DXC

1–100 of 205

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