VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM— 510(k) K123898

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K123898 for VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM, Substantially Equivalent on 2013-01-14. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2012-12-18
Decision date: 2013-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Rancho Cordova,, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.