Cleared Special

K083738 - HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 (FDA 510(k) Clearance)

K083738 · Abbott Vascular · Cardiovascular device

Mar 2009

Decision

85d

Days

Class 2

Risk

K083738 is an FDA 510(k) clearance for the HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on March 11, 2009, 85 days after receiving the submission on December 16, 2008.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K083738 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 16, 2008
Decision Date	March 11, 2009
Days to Decision	85 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF