Embozene Color-Advanced Microspheres

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Boston Scientific

The following data is part of a premarket notification filed by Boston Scientific with the FDA for Embozene Color-advanced Microspheres.

Pre-market Notification Details

Device IDK180102
510k NumberK180102
Device Name:Embozene Color-Advanced Microspheres
ClassificationAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Applicant Boston Scientific 3 Scimed Place Maple Grove,  MN  55311
ContactHeidi Shearer
CorrespondentHeidi Shearer
Boston Scientific 3 Scimed Place Maple Grove,  MN  55311
Product CodeNOY  
Subsequent Product CodeKRD
Subsequent Product CodeNAJ
CFR Regulation Number876.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-16
Decision Date2018-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00810563021523 K180102 000
00810563021516 K180102 000
00810563021509 K180102 000
00810563021493 K180102 000
00810563021066 K180102 000

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