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 IDK093301
510k NumberK093301
Device Name:TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
ClassificationCatheter, Peripheral, Atherectomy
Applicant EV3 INC 3033 Campus Drive Plymouth,  MN  55441
ContactBrenda Johnson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-10-21
Decision Date2009-11-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684065754 K093301 000
00821684065747 K093301 000

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