DeviceClearance

Product code OZT— Cardiovascular

V8 TRANSLUMINAL BAV CATHETER

Classification name
Balloon Aortic Valvuloplasty
Device class
Class 2
Regulation
21 CFR 870.1255
Advisory panel
Cardiovascular
Total cleared
22
First cleared
Most recent

FDA classification definition

“A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.”

— U.S. Food and Drug Administration, device classification record for product code OZT under 21 CFR 870.1255, via openFDA

Market context for product code OZT

FDA has cleared 22 devices under product code OZT between 2012 and 2026, filed by 11 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

Top applicants under product code OZT

Adverse events under product code OZT

product code OZT
Death
20
Other
2
Total
22

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 OZT

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