Cleared Traditional

Elite HV Radial

K173287 · Galt Medical Corp. · Cardiovascular
Dec 2017
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K173287 is an FDA 510(k) clearance for the Elite HV Radial, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 21, 2017, 66 days after receiving the submission on October 16, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K173287 FDA.gov
FDA Decision Cleared SESK
Date Received October 16, 2017
Decision Date December 21, 2017
Days to Decision 66 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