R2P Metacross RX
K-Number: K163479 · 2017-01-11
ApplicantKANEKA Corporation
Decision Date2017-01-11
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
R2P Metacross RX is a medical device manufactured by KANEKA Corporation. It received FDA 510(k) clearance on 2017-01-11 under approval number K163479. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the R2P Metacross RX?
R2P Metacross RX is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by KANEKA Corporation. The 510(k) number is K163479.
When was R2P Metacross RX approved by the FDA?
R2P Metacross RX received FDA 510(k) clearance on 2017-01-11, under approval number K163479.
What company makes R2P Metacross RX?
R2P Metacross RX is manufactured by KANEKA Corporation.
What is the FDA product code for R2P Metacross RX?
The FDA product code for R2P Metacross RX is LIT.
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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.