Cleared Traditional

GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER

K140028 · Galt Medical Corp. · Cardiovascular

Aug 2014

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K140028 is an FDA 510(k) clearance for the GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on August 21, 2014, 227 days after receiving the submission on January 6, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K140028 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2014
Decision Date	August 21, 2014
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF