EPIDUCER LEAD DELIVERY SYSTEM

Electrode, Spinal Epidural

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Epiducer Lead Delivery System.

Pre-market Notification Details

Device IDK110609
510k NumberK110609
Device Name:EPIDUCER LEAD DELIVERY SYSTEM
ClassificationElectrode, Spinal Epidural
Applicant ST. JUDE MEDICAL 6901 PRESTON ROAD Plano,  TX  75024
ContactRashmi Moza
CorrespondentRashmi Moza
ST. JUDE MEDICAL 6901 PRESTON ROAD Plano,  TX  75024
Product CodeLHG  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-03
Decision Date2011-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734403962 K110609 000
05414734403955 K110609 000
05414734401357 K110609 000
15414734400142 K110609 000

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