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 IDK111010
510k NumberK111010
Device Name:SPIDERFX EMBOLIC PROTECTION DEVICE
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant EV3 INC 3033 Campus Drive Plymouth,  MN  55441
ContactBrenda Johnson
CorrespondentBrenda Johnson
EV3 INC 3033 Campus Drive Plymouth,  MN  55441
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-11
Decision Date2011-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684068380 K111010 000
00821684068298 K111010 000
00821684068304 K111010 000
00821684068311 K111010 000
00821684068328 K111010 000
00821684068335 K111010 000
00821684068342 K111010 000
00821684068359 K111010 000
00821684068366 K111010 000
00821684068373 K111010 000
00821684068106 K111010 000

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