TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Catheter, Peripheral, Atherectomy

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Turbohawk Peripheral Plaque Excision System.

Pre-market Notification Details

Device IDK111723
510k NumberK111723
Device Name:TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
ClassificationCatheter, Peripheral, Atherectomy
Applicant EV3 INC 3033 Campus Drive Plymouth,  MN  55441
ContactBrenda Johnson
CorrespondentBrenda Johnson
EV3 INC 3033 Campus Drive Plymouth,  MN  55441
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-20
Decision Date2011-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684074008 K111723 000
00821684065785 K111723 000
00821684047217 K111723 000
00821684047200 K111723 000
00821684047156 K111723 000
00821684047149 K111723 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.