ENDOWAVE INFUSION SYSTEM

Catheter, Continuous Flush

EKOS CORP.

The following data is part of a premarket notification filed by Ekos Corp. with the FDA for Endowave Infusion System.

Pre-market Notification Details

Device IDK071933
510k NumberK071933
Device Name:ENDOWAVE INFUSION SYSTEM
ClassificationCatheter, Continuous Flush
Applicant EKOS CORP. 11911 N CREEK PARKWAY SOUTH Bothell,  WA  98011
ContactJocelyn Kersten
CorrespondentJocelyn Kersten
EKOS CORP. 11911 N CREEK PARKWAY SOUTH Bothell,  WA  98011
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-13
Decision Date2007-08-10
Summary:summary

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