CORE M2 Vascular System
K-Number: K170385 · 2017-04-06
ApplicantVolcano Corporation
Decision Date2017-04-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CORE M2 Vascular System is a medical device manufactured by Volcano Corporation. It received FDA 510(k) clearance on 2017-04-06 under approval number K170385. 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 CORE M2 Vascular System?
CORE M2 Vascular System is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Volcano Corporation. The 510(k) number is K170385.
When was CORE M2 Vascular System approved by the FDA?
CORE M2 Vascular System received FDA 510(k) clearance on 2017-04-06, under approval number K170385.
What company makes CORE M2 Vascular System?
CORE M2 Vascular System is manufactured by Volcano Corporation.
What is the FDA product code for CORE M2 Vascular System?
The FDA product code for CORE M2 Vascular 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.