V8 TRANSLUMINAL BAV CATHETER— 510(k) K132728

Substantially Equivalent

Intervalve, Inc.

FDA 510(k) clearance K132728 for V8 TRANSLUMINAL BAV CATHETER, Substantially Equivalent on 2013-11-22. Applicant: Intervalve, Inc..

Clearance details

Applicant: Intervalve, Inc.
Product code: Code OZT
Advisory panel: Cardiovascular
Date received: 2013-09-03
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.