Cleared Special

CPS DIRECT SL II SLITTABLE OUTER CATHETER

K103250 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular
Jan 2011
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K103250 is an FDA 510(k) clearance for the CPS DIRECT SL II SLITTABLE 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 January 19, 2011, 77 days after receiving the submission on November 3, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K103250 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2010
Decision Date January 19, 2011
Days to Decision 77 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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