Cleared Traditional

K200144 - HI-TORQUE Steelcore Bare Guide Wire
(FDA 510(k) Clearance)

K200144 · Abbott Vascular · Cardiovascular

Apr 2020

Decision

77d

Days

Class 2

Risk

K200144 is an FDA 510(k) clearance for the HI-TORQUE Steelcore Bare Guide Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Abbott Vascular (S,Mta Clara, US). The FDA issued a Cleared decision on April 8, 2020, 77 days after receiving the submission on January 22, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K200144 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2020
Decision Date	April 08, 2020
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF