FDA 510(k)

R2P Destination Slender Guiding Sheath

K-Number: K193125 · 2020-01-06

Decision Date2020-01-06

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

R2P Destination Slender Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2020-01-06 under 510(k) 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. The listed applicant is Terumo Medical Corporation. The 510(k) number is K193125.

When did R2P Destination Slender Guiding Sheath receive FDA 510(k) clearance?

R2P Destination Slender Guiding Sheath received FDA 510(k) clearance on 2020-01-06, under 510(k) number K193125.

Who is the listed applicant for R2P Destination Slender Guiding Sheath?

The FDA 510(k) record lists Terumo Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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.