Cleared Traditional

HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE

K140536 · Lake Region Medical · Cardiovascular
Dec 2014
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K140536 is an FDA 510(k) clearance for the HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Lake Region Medical (Galway, IE). The FDA issued a Cleared decision on December 17, 2014, 288 days after receiving the submission on March 4, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K140536 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2014
Decision Date December 17, 2014
Days to Decision 288 days
Submission Type Traditional
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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