Cleared Traditional

CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

K120298 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular
May 2012
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K120298 is an FDA 510(k) clearance for the CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on May 8, 2012, 98 days after receiving the submission on January 31, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K120298 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2012
Decision Date May 08, 2012
Days to Decision 98 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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