Introcan Safety IV Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

B.Braun Medical Inc.

The following data is part of a premarket notification filed by B.braun Medical Inc. with the FDA for Introcan Safety Iv Catheter.

Pre-market Notification Details

Device IDK220626
510k NumberK220626
Device Name:Introcan Safety IV Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant B.Braun Medical Inc. 901 Marcon Blvd. Allentown,  PA  18109
ContactTracy Larish
CorrespondentTracy Larish
B.Braun Medical Inc. 901 Marcon Blvd. Allentown,  PA  18109
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-05-14

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