EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.

Stylet, Catheter

GUIDANT CORPORATION

The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Easytrak 2 Stylet, Models 4826, 4829, 4832..

Pre-market Notification Details

Device IDK052965
510k NumberK052965
Device Name:EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
ClassificationStylet, Catheter
Applicant GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul,  MN  55112 -5798
ContactLinda Kleinsasser
CorrespondentLinda Kleinsasser
GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul,  MN  55112 -5798
Product CodeDRB  
CFR Regulation Number870.1380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-21
Decision Date2006-02-13
Summary:summary

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