AGILTRAC .035 PERIPHERAL DILATATION CATHETER

Catheter, Percutaneous

GUIDANT CORP.

The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Agiltrac .035 Peripheral Dilatation Catheter.

Pre-market Notification Details

Device IDK023320
510k NumberK023320
Device Name:AGILTRAC .035 PERIPHERAL DILATATION CATHETER
ClassificationCatheter, Percutaneous
Applicant GUIDANT CORP. 1525 O'BRIEN DR. Menlo Park,  CA  94025
ContactMichelle Grossman
CorrespondentMichelle Grossman
GUIDANT CORP. 1525 O'BRIEN DR. Menlo Park,  CA  94025
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-04
Decision Date2002-12-10
Summary:summary

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