Actreen Hi-Lite Intermittent Urinary Catheters

Catheter, Urethral

B. Braun Medical Inc.

The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Actreen Hi-lite Intermittent Urinary Catheters.

Pre-market Notification Details

Device IDK192577
510k NumberK192577
Device Name:Actreen Hi-Lite Intermittent Urinary Catheters
ClassificationCatheter, Urethral
Applicant B. Braun Medical Inc. 901 Marcon Boulevard Allentown,  PA  18109
ContactAnita J. Nemeth
CorrespondentAnita J. Nemeth
B. Braun Medical Inc. 901 Marcon Boulevard Allentown,  PA  18109
Product CodeGBM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-19
Decision Date2020-05-07

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