Endophys Pressure Sensing Sheath Kit

FDA 510(k) K180620 · Endophys Holdings, LLC

Substantially Equivalent

510(k) numberK180620

Submission

Device name
Endophys Pressure Sensing Sheath Kit
Applicant
Endophys Holdings, LLC
Dallas, TX, US
Received
March 9, 2018
Decision date
October 12, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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More from Protaryx Medical, Inc.

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K190098Endophys Pressure Sensing SheathDYB · Special 03/07/2019SE
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Questions and answers

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

Endophys Pressure Sensing Sheath Kit (K180620) received a 510(k) decision of Substantially Equivalent on October 12, 2018, 217 days after the submission was received.

What is the product code of K180620?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.