VariAx 2 System
K-Number: K180500 · 2018-06-04
ApplicantStryker GmbH
Decision Date2018-06-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VariAx 2 System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2018-06-04 under approval number K180500. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VariAx 2 System?
VariAx 2 System is a medical device that received FDA 510(k) clearance on 2018-06-04. It is manufactured by Stryker GmbH. The 510(k) number is K180500.
When was VariAx 2 System approved by the FDA?
VariAx 2 System received FDA 510(k) clearance on 2018-06-04, under approval number K180500.
What company makes VariAx 2 System?
VariAx 2 System is manufactured by Stryker GmbH.
What is the FDA product code for VariAx 2 System?
The FDA product code for VariAx 2 System is HWC. This falls under the Cardiovascular category.
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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.