TURBOHAWK PEROPHERAL 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 Peropheral Plaque Excision System.

Pre-market Notification Details

Device IDK103618
510k NumberK103618
Device Name:TURBOHAWK PEROPHERAL 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 Received2010-12-10
Decision Date2011-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684065853 K103618 000
00821684065839 K103618 000
00821684065815 K103618 000
00821684047941 K103618 000
00821684047934 K103618 000
00821684047927 K103618 000
00643169968226 K103618 000
00643169968202 K103618 000

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