HydroPearl Microspheres

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

MicroVention, Inc.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydropearl Microspheres.

Pre-market Notification Details

Device IDK192684
510k NumberK192684
Device Name:HydroPearl Microspheres
ClassificationAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Applicant MicroVention, Inc. 35 Enterprise Aliso Viejo,  CA  92656
ContactAnalia Staubly
CorrespondentAnalia Staubly
MicroVention, Inc. 35 Enterprise Aliso Viejo,  CA  92656
Product CodeNOY  
Subsequent Product CodeKRD
Subsequent Product CodeNAJ
CFR Regulation Number876.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-01-22

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