VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING— 510(k) K122578

Substantially Equivalent

Vital Images, Inc.

FDA 510(k) clearance K122578 for VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING, Substantially Equivalent on 2013-02-25. Applicant: Vital Images, Inc..

Clearance details

Applicant: Vital Images, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-08-23
Decision date: 2013-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.