Cleared Traditional

Endophys Pressure Sensing Sheath Kit- 8F

K173399 · Endophys Holdings, LLC · Cardiovascular
Nov 2017
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K173399 is an FDA 510(k) clearance for the Endophys Pressure Sensing Sheath Kit- 8F, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Endophys Holdings, LLC (Dallas, US). The FDA issued a Cleared decision on November 30, 2017, 30 days after receiving the submission on October 31, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K173399 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2017
Decision Date November 30, 2017
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340