AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304

Introducer, Catheter

ST. JUDE MEDICAL, DAIG DIVISION, INC.

The following data is part of a premarket notification filed by St. Jude Medical, Daig Division, Inc. with the FDA for Agilis Steerable Catheter Introducer, Model 408304.

Pre-market Notification Details

Device IDK042623
510k NumberK042623
Device Name:AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
ClassificationIntroducer, Catheter
Applicant ST. JUDE MEDICAL, DAIG DIVISION, INC. 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
ContactJennifer Nevison
CorrespondentJennifer Nevison
ST. JUDE MEDICAL, DAIG DIVISION, INC. 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-27
Decision Date2005-01-27
Summary:summary

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