R2P Destination Slender Guiding Sheath
K-Number: K193125 · 2020-01-06
ApplicantTerumo Medical Corporation
Decision Date2020-01-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
R2P Destination Slender Guiding Sheath is a medical device manufactured by Terumo Medical Corporation. It received FDA 510(k) clearance on 2020-01-06 under approval number K193125. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the R2P Destination Slender Guiding Sheath?
R2P Destination Slender Guiding Sheath is a medical device that received FDA 510(k) clearance on 2020-01-06. It is manufactured by Terumo Medical Corporation. The 510(k) number is K193125.
When was R2P Destination Slender Guiding Sheath approved by the FDA?
R2P Destination Slender Guiding Sheath received FDA 510(k) clearance on 2020-01-06, under approval number K193125.
What company makes R2P Destination Slender Guiding Sheath?
R2P Destination Slender Guiding Sheath is manufactured by Terumo Medical Corporation.
What is the FDA product code for R2P Destination Slender Guiding Sheath?
The FDA product code for R2P Destination Slender Guiding Sheath is DYB.
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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.