RX ACCUNET EMBOLIC PROTECTION SYSTEM

Temporary Carotid Catheter For Embolic Capture

GUIDANT CORPORATION

The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Rx Accunet Embolic Protection System.

Pre-market Notification Details

Device IDK052165
510k NumberK052165
Device Name:RX ACCUNET EMBOLIC PROTECTION SYSTEM
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant GUIDANT CORPORATION 3200 Lakeside Drive Santa Clara,  CA  95054
ContactJulia Anastas
CorrespondentJulia Anastas
GUIDANT CORPORATION 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-09
Decision Date2005-08-16
Summary:summary

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