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FDA 510(k)

Endophys Pressure Sensing Sheath Kit

K-Number: K160272 · 2016-03-04

ApplicantEndophys, Inc.
Decision Date2016-03-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Pressure Sensing Sheath Kit is a medical device manufactured by Endophys, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K160272. 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 2016-03-04. It is manufactured by Endophys, Inc.. The 510(k) number is K160272.

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

Endophys Pressure Sensing Sheath Kit received FDA 510(k) clearance on 2016-03-04, under approval number K160272.

What company makes Endophys Pressure Sensing Sheath Kit?

Endophys Pressure Sensing Sheath Kit is manufactured by Endophys, Inc..

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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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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