ExsoMed ArcPhix and ExsoMed ArrowPhix
K-Number: K171407 · 2017-08-18
ApplicantExsomed Holding Company, LLC
Decision Date2017-08-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ExsoMed ArcPhix and ExsoMed ArrowPhix is a medical device manufactured by Exsomed Holding Company, LLC. It received FDA 510(k) clearance on 2017-08-18 under approval number K171407. 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 ExsoMed ArcPhix and ExsoMed ArrowPhix?
ExsoMed ArcPhix and ExsoMed ArrowPhix is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Exsomed Holding Company, LLC. The 510(k) number is K171407.
When was ExsoMed ArcPhix and ExsoMed ArrowPhix approved by the FDA?
ExsoMed ArcPhix and ExsoMed ArrowPhix received FDA 510(k) clearance on 2017-08-18, under approval number K171407.
What company makes ExsoMed ArcPhix and ExsoMed ArrowPhix?
ExsoMed ArcPhix and ExsoMed ArrowPhix is manufactured by Exsomed Holding Company, LLC.
What is the FDA product code for ExsoMed ArcPhix and ExsoMed ArrowPhix?
The FDA product code for ExsoMed ArcPhix and ExsoMed ArrowPhix 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.