SPIDERFX EMBOLIC PROTECTION DEVICE

Temporary Carotid Catheter For Embolic Capture

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Spiderfx Embolic Protection Device.

Pre-market Notification Details

Device IDK063204
510k NumberK063204
Device Name:SPIDERFX EMBOLIC PROTECTION DEVICE
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant EV3 INC 9600 54TH AVENUE NORTH Plymouth,  MN  55442 -2920
ContactDavid Worrell
CorrespondentDavid Worrell
EV3 INC 9600 54TH AVENUE NORTH Plymouth,  MN  55442 -2920
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-23
Decision Date2006-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684068380 K063204 000
00821684068304 K063204 000
00821684068311 K063204 000
00821684068328 K063204 000
00821684068335 K063204 000
00821684068342 K063204 000
00821684068359 K063204 000
00821684068366 K063204 000
00821684068373 K063204 000
00821684068298 K063204 000

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