R2P Navicross
K-Number: K231044 · 2023-07-27
ApplicantTerumo Medical Corporation
Decision Date2023-07-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
R2P Navicross is a medical device manufactured by Terumo Medical Corporation. It received FDA 510(k) clearance on 2023-07-27 under approval number K231044. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the R2P Navicross?
R2P Navicross is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Terumo Medical Corporation. The 510(k) number is K231044.
When was R2P Navicross approved by the FDA?
R2P Navicross received FDA 510(k) clearance on 2023-07-27, under approval number K231044.
What company makes R2P Navicross?
R2P Navicross is manufactured by Terumo Medical Corporation.
What is the FDA product code for R2P Navicross?
The FDA product code for R2P Navicross is DQY.
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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.