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FDA 510(k)

Endophys Pressure Sensing Sheath Kit- 8F

K-Number: K173399 · 2017-11-30

ApplicantEndophys Holdings, LLC
Decision Date2017-11-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Pressure Sensing Sheath Kit- 8F is a medical device manufactured by Endophys Holdings, LLC. It received FDA 510(k) clearance on 2017-11-30 under approval number K173399. 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- 8F?

Endophys Pressure Sensing Sheath Kit- 8F is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Endophys Holdings, LLC. The 510(k) number is K173399.

When was Endophys Pressure Sensing Sheath Kit- 8F approved by the FDA?

Endophys Pressure Sensing Sheath Kit- 8F received FDA 510(k) clearance on 2017-11-30, under approval number K173399.

What company makes Endophys Pressure Sensing Sheath Kit- 8F?

Endophys Pressure Sensing Sheath Kit- 8F is manufactured by Endophys Holdings, LLC.

What is the FDA product code for Endophys Pressure Sensing Sheath Kit- 8F?

The FDA product code for Endophys Pressure Sensing Sheath Kit- 8F is DYB.

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Other Devices by Endophys Holdings, LLC

K160945Endophys Blood Pressure Monitor K180620Endophys Pressure Sensing Sheath Kit 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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