TRANSIT INFUSION CATHETER

Catheter, Continuous Flush

CORDIS NEUROVASCULAR, INC.

The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Transit Infusion Catheter.

Pre-market Notification Details

Device IDK952874
510k NumberK952874
Device Name:TRANSIT INFUSION CATHETER
ClassificationCatheter, Continuous Flush
Applicant CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactMarlene Wright Valenti
CorrespondentMarlene Wright Valenti
CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-23
Decision Date1995-08-21

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