ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM

System, Hypothermia, Intravenous, Cooling

ALSIUS CORP.

The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Alsius Coolgard 3000 & Alsius Catheter System.

Pre-market Notification Details

Device IDK030421
510k NumberK030421
Device Name:ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
ClassificationSystem, Hypothermia, Intravenous, Cooling
Applicant ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine,  CA  92618
ContactKenneth A Collins
CorrespondentKenneth A Collins
ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine,  CA  92618
Product CodeNCX  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-10
Decision Date2003-10-23
Summary:summary

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