Cleared Special

Endophys Pressure Sensing Sheath Kit

K180620 · Endophys Holdings, LLC · Cardiovascular
Oct 2018
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K180620 is an FDA 510(k) clearance for the Endophys Pressure Sensing Sheath Kit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Endophys Holdings, LLC (Dallas, US). The FDA issued a Cleared decision on October 12, 2018, 217 days after receiving the submission on March 9, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K180620 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2018
Decision Date October 12, 2018
Days to Decision 217 days
Submission Type Special
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