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FDA 510(k)

Endophys Pressure Sensing Sheath Kit

K-Number: K180620 · 2018-10-12

ApplicantEndophys Holdings, LLC
Decision Date2018-10-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Pressure Sensing Sheath Kit is a medical device manufactured by Endophys Holdings, LLC. It received FDA 510(k) clearance on 2018-10-12 under approval number K180620. 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 Kit?

Endophys Pressure Sensing Sheath Kit is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Endophys Holdings, LLC. The 510(k) number is K180620.

When was Endophys Pressure Sensing Sheath Kit approved by the FDA?

Endophys Pressure Sensing Sheath Kit received FDA 510(k) clearance on 2018-10-12, under approval number K180620.

What company makes Endophys Pressure Sensing Sheath Kit?

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

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

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

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Other Devices by Endophys Holdings, LLC

K160945Endophys Blood Pressure Monitor K173399Endophys Pressure Sensing Sheath Kit- 8F K190098Endophys Pressure Sensing Sheath

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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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