REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) 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 (mvp) System.

Pre-market Notification Details

Device IDK133282
510k NumberK133282
Device Name:REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
ClassificationDevice, Vascular, For Promoting Embolization
Applicant REVERSE MEDICAL CORPORATION 13700 Alton Parkway Suite 167 Irvine,  CA  92618
ContactJeffrey Valko
CorrespondentJeffrey Valko
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 Received2013-10-25
Decision Date2013-11-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536003835 K133282 000
00847536003606 K133282 000

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