Endophys Pressure Sensing Sheath Kit

FDA 510(k) K141275 · Endophys, Inc.

Substantially Equivalent

510(k) numberK141275

Submission

Device name
Endophys Pressure Sensing Sheath Kit
Applicant
Endophys, Inc.
Sunnyvale, CA, US
Received
May 16, 2014
Decision date
January 7, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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Questions and answers

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

Endophys Pressure Sensing Sheath Kit (K141275) received a 510(k) decision of Substantially Equivalent on January 7, 2015, 236 days after the submission was received.

What is the product code of K141275?

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