SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz— 510(k) K153369

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K153369 for SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz, Substantially Equivalent on 2015-12-22. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2015-11-23
Decision date: 2015-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, 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.