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FDA 510(k)

VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM

K-Number: K132659 · 2013-09-27

ApplicantVolcano Corporation
Decision Date2013-09-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VOLCANO PREVIEW FORWARD-LOOKING IVUS 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 2013-09-27 under 510(k) number K132659. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM?

VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Volcano Corporation. The 510(k) number is K132659.

When did VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM receive FDA 510(k) clearance?

VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM received FDA 510(k) clearance on 2013-09-27, under 510(k) number K132659.

Who is the listed applicant for VOLCANO PREVIEW FORWARD-LOOKING IVUS 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 PREVIEW FORWARD-LOOKING IVUS SYSTEM?

The FDA product code for VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM is DQY.

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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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