PERIFIX CATHETER AND CONTIPLEX CATHETER

Catheter, Conduction, Anesthetic

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perifix Catheter And Contiplex Catheter.

Pre-market Notification Details

Device IDK042488
510k NumberK042488
Device Name:PERIFIX CATHETER AND CONTIPLEX CATHETER
ClassificationCatheter, Conduction, Anesthetic
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactAmy Smith
CorrespondentAmy Smith
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeBSO  
CFR Regulation Number868.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-13
Decision Date2004-09-30
Summary:summary

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