SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET

Set, Administration, Intravascular

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Smartport Ct Mp Port Access System And Lifeguard Ct Safety Infusion Set.

Pre-market Notification Details

Device IDK072375
510k NumberK072375
Device Name:SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactBrian Kunst
CorrespondentBrian Kunst
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-23
Decision Date2007-12-13
Summary:summary

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