Volcano Therapeutics, Inc. Volcano Ivus System

FDA 510(k) K042188 · Volcano Therapeutics, Inc.

Substantially Equivalent

510(k) numberK042188

Submission

Device name
Volcano Therapeutics, Inc. Volcano Ivus System
Applicant
Volcano Therapeutics, Inc.
Rancho Cordova,, CA, US
Received
August 12, 2004
Decision date
November 10, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was Volcano Therapeutics, Inc. Volcano Ivus System cleared by the FDA?

Volcano Therapeutics, Inc. Volcano Ivus System (K042188) received a 510(k) decision of Substantially Equivalent on November 10, 2004, 90 days after the submission was received.

What is the product code of K042188?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.