AortaSTAT Occlusion Device

Catheter, Intravascular Occluding, Temporary

RenalPro Medical, Inc.

The following data is part of a premarket notification filed by Renalpro Medical, Inc. with the FDA for Aortastat Occlusion Device.

Pre-market Notification Details

Device IDK210602
510k NumberK210602
Device Name:AortaSTAT Occlusion Device
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant RenalPro Medical, Inc. 2370-B Walsh Avenue Santa Clara,  CA  95051
ContactJames Twitchell
CorrespondentRoberta Hines
Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville,  WA  98077
Product CodeMJN  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-07-09

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.