Cleared Traditional

K120296 - CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
(FDA 510(k) Clearance)

K120296 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular

May 2012

Decision

101d

Days

Class 2

Risk

K120296 is an FDA 510(k) clearance for the CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on May 11, 2012, 101 days after receiving the submission on January 31, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K120296 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2012
Decision Date	May 11, 2012
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF