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FDA 510(k)

R2P SlenGuide

K-Number: K161546 · 2016-10-14

ApplicantAshitaka Factory of Terumo Corporation
Decision Date2016-10-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R2P SlenGuide is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2016-10-14 under 510(k) 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. The listed applicant is Ashitaka Factory of Terumo Corporation. The 510(k) number is K161546.

When did R2P SlenGuide receive FDA 510(k) clearance?

R2P SlenGuide received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161546.

Who is the listed applicant for R2P SlenGuide?

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

What is the FDA product code for R2P SlenGuide?

The FDA product code for R2P SlenGuide is DQY.

Other records listing Ashitaka Factory of Terumo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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