AGILIS NXT STEERABLE INTRODUCER

Introducer, Catheter

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Agilis Nxt Steerable Introducer.

Pre-market Notification Details

Device IDK110450
510k NumberK110450
Device Name:AGILIS NXT STEERABLE INTRODUCER
ClassificationIntroducer, Catheter
Applicant ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka,  MN  55345
ContactWendy Pinor
CorrespondentWendy Pinor
ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka,  MN  55345
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-16
Decision Date2011-05-10
Summary:summary

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