Reverse Medical Micro Vascular Plug System

Device, Vascular, For Promoting Embolization

REVERSE MEDICAL CORPORATION

The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Micro Vascular Plug System.

Pre-market Notification Details

Device IDK150108
510k NumberK150108
Device Name:Reverse Medical Micro Vascular Plug System
ClassificationDevice, Vascular, For Promoting Embolization
Applicant REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY, SUITE 167 Irvine,  CA  92618
ContactLaura Heaton
CorrespondentLaura Heaton
REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY, SUITE 167 Irvine,  CA  92618
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-20
Decision Date2015-04-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536027732 K150108 000
00763000702113 K150108 000
00763000307806 K150108 000
00763000307813 K150108 000
00763000307769 K150108 000
00763000307776 K150108 000
00847536020825 K150108 000
00847536003637 K150108 000
00847536004009 K150108 000
00847536020832 K150108 000
00847536025431 K150108 000
00763000702106 K150108 000

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