ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM

Temporary Carotid Catheter For Embolic Capture

GUIDANT CORP.

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

Pre-market Notification Details

Device IDK042218
510k NumberK042218
Device Name:ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
ContactLaraine Pangelina
CorrespondentLaraine Pangelina
GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-05
Decision Date2004-08-31
Summary:summary

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