Cleared Traditional

ENDOPHYS PRESSURE SENSING SHEATH KIT

K141275 · Endophys, Inc. · Cardiovascular
Jan 2015
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K141275 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. (Sunnyvale, US). The FDA issued a Cleared decision on January 7, 2015, 236 days after receiving the submission on May 16, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K141275 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2014
Decision Date January 07, 2015
Days to Decision 236 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