Cleared Traditional

Coaxial Dilator Set (Micro-Introducer)

K172487 · Galt Medical Corp. · Cardiovascular
Oct 2017
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K172487 is an FDA 510(k) clearance for the Coaxial Dilator Set (Micro-Introducer), a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on October 16, 2017, 60 days after receiving the submission on August 17, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K172487 FDA.gov
FDA Decision Cleared SESK
Date Received August 17, 2017
Decision Date October 16, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRE — Dilator, Vessel, For Percutaneous Catheterization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1310

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