VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS— 510(k) K140291

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K140291 for VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS, Substantially Equivalent on 2014-03-07. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2014-02-05
Decision date: 2014-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Billerica, MA, US

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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.