CPS DIRECT SL II SLITTABLE OUTER CATHETER

Catheter, Percutaneous

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI

The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Cps Direct Sl Ii Slittable Outer Catheter.

Pre-market Notification Details

Device IDK103250
510k NumberK103250
Device Name:CPS DIRECT SL II SLITTABLE OUTER CATHETER
ClassificationCatheter, Percutaneous
Applicant ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar,  CA  91342
ContactColleen Canan
CorrespondentColleen Canan
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar,  CA  91342
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-03
Decision Date2011-01-19

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