ACUITY STEERABLE STYLET ACCESSORY

Stylet, Catheter

GUIDANT CORPORATION

The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Acuity Steerable Stylet Accessory.

Pre-market Notification Details

Device IDK053019
510k NumberK053019
Device Name:ACUITY STEERABLE STYLET ACCESSORY
ClassificationStylet, Catheter
Applicant GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul,  MN  55112 -5798
ContactJennifer X Tang
CorrespondentJennifer X Tang
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 Received2005-10-26
Decision Date2006-03-03
Summary:summary

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