HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

Catheter, Peripheral, Atherectomy

COVIDIEN, LLC

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Hawkone Directional Atherectomy System.

Pre-market Notification Details

Device IDK141801
510k NumberK141801
Device Name:HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
ClassificationCatheter, Peripheral, Atherectomy
Applicant COVIDIEN, LLC 3033 CAMPUS DRIVE Plymouth,  MN  55442
ContactJulie Underdahl
CorrespondentJulie Underdahl
COVIDIEN, LLC 3033 CAMPUS DRIVE Plymouth,  MN  55442
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-03
Decision Date2014-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169968554 K141801 000
00643169968509 K141801 000
00643169968486 K141801 000
00821684073551 K141801 000
00821684057964 K141801 000
00821684057933 K141801 000
00821684057926 K141801 000
00763000202699 K141801 000

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