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FDA 510(k)

Endophys Pressure Sensing Sheath

K-Number: K190098 · 2019-03-07

ApplicantEndophys Holdings, LLC
Decision Date2019-03-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Pressure Sensing Sheath is a medical device manufactured by Endophys Holdings, LLC. It received FDA 510(k) clearance on 2019-03-07 under approval number K190098. 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 Endophys Pressure Sensing Sheath?

Endophys Pressure Sensing Sheath is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Endophys Holdings, LLC. The 510(k) number is K190098.

When was Endophys Pressure Sensing Sheath approved by the FDA?

Endophys Pressure Sensing Sheath received FDA 510(k) clearance on 2019-03-07, under approval number K190098.

What company makes Endophys Pressure Sensing Sheath?

Endophys Pressure Sensing Sheath is manufactured by Endophys Holdings, LLC.

What is the FDA product code for Endophys Pressure Sensing Sheath?

The FDA product code for Endophys Pressure Sensing Sheath is DYB.

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Other Devices by Endophys Holdings, LLC

K160945Endophys Blood Pressure Monitor K173399Endophys Pressure Sensing Sheath Kit- 8F K180620Endophys Pressure Sensing Sheath Kit

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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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