SAFETY INTRODUCER NEEDLE

Introducer, Catheter

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Safety Introducer Needle.

Pre-market Notification Details

Device IDK030135
510k NumberK030135
Device Name:SAFETY INTRODUCER NEEDLE
ClassificationIntroducer, Catheter
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactAmy K Smith
CorrespondentAmy K Smith
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-14
Decision Date2003-07-15
Summary:summary

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