CRUX VENA CAVA FILTER SYSTEM

Filter, Intravascular, Cardiovascular

CRUX BIOMEDICAL

The following data is part of a premarket notification filed by Crux Biomedical with the FDA for Crux Vena Cava Filter System.

Pre-market Notification Details

Device IDK122585
510k NumberK122585
Device Name:CRUX VENA CAVA FILTER SYSTEM
ClassificationFilter, Intravascular, Cardiovascular
Applicant CRUX BIOMEDICAL 1455 ADAMS DRIVE, #1170 Menlo Park,  CA  94025
ContactElisa Hebb
CorrespondentElisa Hebb
CRUX BIOMEDICAL 1455 ADAMS DRIVE, #1170 Menlo Park,  CA  94025
Product CodeDTK  
CFR Regulation Number870.3375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-24
Decision Date2013-01-17
Summary:summary

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