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 IDK141313
510k NumberK141313
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
ContactJane Metcalf
CorrespondentJane Metcalf
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 Received2014-05-20
Decision Date2014-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536004351 K141313 000
00763000702090 K141313 000
00763000307783 K141313 000
00763000307790 K141313 000
00763000307745 K141313 000
00763000307752 K141313 000
00847536003613 K141313 000
00847536003620 K141313 000
00847536004344 K141313 000
00763000702083 K141313 000

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