R2P SlenGuide
K-Number: K161546 · 2016-10-14
Decision Date2016-10-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
R2P SlenGuide is a medical device manufactured by Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2016-10-14 under approval number K161546. 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 SlenGuide?
R2P SlenGuide is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Ashitaka Factory of Terumo Corporation. The 510(k) number is K161546.
When was R2P SlenGuide approved by the FDA?
R2P SlenGuide received FDA 510(k) clearance on 2016-10-14, under approval number K161546.
What company makes R2P SlenGuide?
R2P SlenGuide is manufactured by Ashitaka Factory of Terumo Corporation.
What is the FDA product code for R2P SlenGuide?
The FDA product code for R2P SlenGuide 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.