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FDA 510(k)

M-Y Sheath

K-Number: K190369 · 2019-04-17

ApplicantRam Medical Innovations, Inc.
Decision Date2019-04-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M-Y Sheath is a medical device manufactured by Ram Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-04-17 under approval number K190369. 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 M-Y Sheath?

M-Y Sheath is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Ram Medical Innovations, Inc.. The 510(k) number is K190369.

When was M-Y Sheath approved by the FDA?

M-Y Sheath received FDA 510(k) clearance on 2019-04-17, under approval number K190369.

What company makes M-Y Sheath?

M-Y Sheath is manufactured by Ram Medical Innovations, Inc..

What is the FDA product code for M-Y Sheath?

The FDA product code for M-Y 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.

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