K123111

Substantially Equivalent

V8 TRANSLUMINAL BAV CATHETER

Applicant: Intervalve, Inc.
Product code: OZT
Advisory panel: Cardiovascular
Date received: 2012-10-03
Decision date: 2013-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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