Cleared Traditional

VenaCure EVLT NeverTouch Direct Introducer Sheath

K170695 · AngioDynamics, Inc. · Cardiovascular
May 2017
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K170695 is an FDA 510(k) clearance for the VenaCure EVLT NeverTouch Direct Introducer Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on May 30, 2017, 84 days after receiving the submission on March 7, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K170695 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2017
Decision Date May 30, 2017
Days to Decision 84 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

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