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FDA 510(k)

VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM

K-Number: K060483 · 2006-06-23

ApplicantVolcano Corporation
Decision Date2006-06-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K060483. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM?

VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Volcano Corporation. The 510(k) number is K060483.

When did VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM receive FDA 510(k) clearance?

VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM received FDA 510(k) clearance on 2006-06-23, under 510(k) number K060483.

Who is the listed applicant for VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM?

The FDA 510(k) record lists Volcano Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM?

The FDA product code for VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM is IYO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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