Cleared Traditional

Mini Stick ENVI Non-Vascular Introducer Kit

K170775 · AngioDynamics, Inc. · Cardiovascular
Jul 2017
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K170775 is an FDA 510(k) clearance for the Mini Stick ENVI Non-Vascular Introducer Kit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on July 19, 2017, 127 days after receiving the submission on March 14, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K170775 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2017
Decision Date July 19, 2017
Days to Decision 127 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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