IntraSight
K-Number: K190078 · 2019-02-11
ApplicantVolcano Corporation
Decision Date2019-02-11
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
IntraSight is a medical device manufactured by Volcano Corporation. It received FDA 510(k) clearance on 2019-02-11 under approval number K190078. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IntraSight?
IntraSight is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by Volcano Corporation. The 510(k) number is K190078.
When was IntraSight approved by the FDA?
IntraSight received FDA 510(k) clearance on 2019-02-11, under approval number K190078.
What company makes IntraSight?
IntraSight is manufactured by Volcano Corporation.
What is the FDA product code for IntraSight?
The FDA product code for IntraSight is DSA.
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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.