DeviceClearance

Product code DXZ— Cardiovascular

CHASE CARDIOVASCULAR PATCH

Classification name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device class
Class 2
Regulation
21 CFR 870.3470
Advisory panel
Cardiovascular
Total cleared
90
First cleared
Most recent

Market context for product code DXZ

FDA has cleared 90 devices under product code DXZ between 1977 and 2025, filed by 41 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 DXZ

Adverse events under product code DXZ

product code DXZ
Death
19
Injury
265
Total
284

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 DXZ

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