IntraSight— 510(k) K190078

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K190078 for IntraSight, Substantially Equivalent on 2019-02-11. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2019-01-16
Decision date: 2019-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.