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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2017-04-06 under 510(k) 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. The listed applicant is Volcano Corporation. The 510(k) number is K170385.

When did CORE M2 Vascular System receive FDA 510(k) clearance?

CORE M2 Vascular System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K170385.

Who is the listed applicant for CORE M2 Vascular 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 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.

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