AGILITY STEERABLE GUIDEWIRE

Wire, Guide, Catheter

CORDIS NEUROVASCULAR, INC.

The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Agility Steerable Guidewire.

Pre-market Notification Details

Device IDK991646
510k NumberK991646
Device Name:AGILITY STEERABLE GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes,  FL  33014
ContactMaritza Celaya
CorrespondentMaritza Celaya
CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes,  FL  33014
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-13
Decision Date1999-09-23
Summary:summary

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