Cleared Special

GALT MEDICAL GUIDEWIRE

K021990 · Galt Medical Corp. · Cardiovascular
Jul 2002
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K021990 is an FDA 510(k) clearance for the GALT MEDICAL GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on July 18, 2002, 30 days after receiving the submission on June 18, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K021990 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2002
Decision Date July 18, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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