ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE

About This 510(k) Submission

K992169 is an FDA 510(k) clearance for the ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 28, 1999, 122 days after receiving the submission on June 28, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.