U-CLIP DEVICE

Clip, Implantable

MEDTRONIC NEUROSURGERY

The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for U-clip Device.

Pre-market Notification Details

Device IDK062821
510k NumberK062821
Device Name:U-CLIP DEVICE
ClassificationClip, Implantable
Applicant MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
ContactJeffrey Henderson
CorrespondentJeffrey Henderson
MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-20
Decision Date2006-12-19
Summary:summary

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