EDWARDS PERIPHERAL DILATION CATHETER

Catheter, Percutaneous

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Peripheral Dilation Catheter.

Pre-market Notification Details

Device IDK052149
510k NumberK052149
Device Name:EDWARDS PERIPHERAL DILATION CATHETER
ClassificationCatheter, Percutaneous
Applicant EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
ContactKevin Drisko
CorrespondentKevin Drisko
EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-08
Decision Date2005-09-02
Summary:summary

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