ER-REBOA Catheter

Catheter, Intravascular Occluding, Temporary

Prytime Medical Devices, Inc

The following data is part of a premarket notification filed by Prytime Medical Devices, Inc with the FDA for Er-reboa Catheter.

Pre-market Notification Details

Device IDK170411
510k NumberK170411
Device Name:ER-REBOA Catheter
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant Prytime Medical Devices, Inc 229 North Main Street Boerne,  TX  78006
ContactBrian Young
CorrespondentBrian Young
Prytime Medical Devices, Inc 229 North Main Street Boerne,  TX  78006
Product CodeMJN  
Subsequent Product CodeDQO
Subsequent Product CodeDQY
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-10
Decision Date2017-04-04
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.