Cleared Special

K160272 - Endophys Pressure Sensing Sheath Kit
(FDA 510(k) Clearance)

K160272 · Endophys, Inc. · Cardiovascular
Mar 2016
Decision
31d
Days
Class 2
Risk

K160272 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, Inc. (Dallas, US). The FDA issued a Cleared decision on March 4, 2016, 31 days after receiving the submission on February 2, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K160272 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2016
Decision Date March 04, 2016
Days to Decision 31 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