TIVA¿— 510(k) K152924

Substantially Equivalent

Velano Vascular

FDA 510(k) clearance K152924 for TIVA¿, Substantially Equivalent on 2016-01-07. Applicant: Velano Vascular.

Clearance details

Applicant: Velano Vascular
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2015-10-05
Decision date: 2016-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.