Cleared Special

GALTSTICK INTRODUCER SYSTEM

K071330 · Galt Medical Corp. · Cardiovascular
Oct 2007
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K071330 is an FDA 510(k) clearance for the GALTSTICK INTRODUCER SYSTEM, 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 31, 2007, 173 days after receiving the submission on May 11, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K071330 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2007
Decision Date October 31, 2007
Days to Decision 173 days
Submission Type Special
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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