PREBOA-PRO 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 Preboa-pro Catheter.

Pre-market Notification Details

Device IDK200459
510k NumberK200459
Device Name:PREBOA-PRO 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 Received2020-02-25
Decision Date2020-06-03

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