MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER

Shunt, Central Nervous System And Components

MEDTRONIC NEUROSURGERY

The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Ares Antibiotic-impregnated Catheter.

Pre-market Notification Details

Device IDK110560
510k NumberK110560
Device Name:MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
ClassificationShunt, Central Nervous System And Components
Applicant MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
ContactJeffrey Henderson
CorrespondentJeffrey Henderson
MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2011-02-28
Decision Date2011-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169288885 K110560 000
00643169762664 K110560 000
00643169762657 K110560 000
00643169762640 K110560 000
00643169474956 K110560 000
00643169474949 K110560 000
00643169474932 K110560 000
00643169288874 K110560 000
00643169288867 K110560 000

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