Endophys Pressure Sensing Sheath Kit- 8F

FDA 510(k) K173399 · Endophys Holdings, LLC

Substantially Equivalent

510(k) numberK173399

Submission

Device name
Endophys Pressure Sensing Sheath Kit- 8F
Applicant
Endophys Holdings, LLC
Dallas, TX, US
Received
October 31, 2017
Decision date
November 30, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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- 8F cleared by the FDA?

Endophys Pressure Sensing Sheath Kit- 8F (K173399) received a 510(k) decision of Substantially Equivalent on November 30, 2017, 30 days after the submission was received.

What is the product code of K173399?

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