REVERSE MEDICAL REFLEX GUIDE CATHETER

Catheter, Percutaneous

REVERSE MEDICAL CORPORATION

The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Reflex Guide Catheter.

Pre-market Notification Details

Device IDK110055
510k NumberK110055
Device Name:REVERSE MEDICAL REFLEX GUIDE CATHETER
ClassificationCatheter, Percutaneous
Applicant REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY SUITE 167 Irvine,  CA  92618
ContactAmy Eskina
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-01-10
Decision Date2011-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00847536000018 K110055 000

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