AFX INTRODUCER SYSTEM

Introducer, Catheter

ENDOLOGIX, INC.

The following data is part of a premarket notification filed by Endologix, Inc. with the FDA for Afx Introducer System.

Pre-market Notification Details

Device IDK120212
510k NumberK120212
Device Name:AFX INTRODUCER SYSTEM
ClassificationIntroducer, Catheter
Applicant ENDOLOGIX, INC. 11 STUDEBAKER Irvine,  CA  92610
ContactJanet M Fauls
CorrespondentJanet M Fauls
ENDOLOGIX, INC. 11 STUDEBAKER Irvine,  CA  92610
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-24
Decision Date2012-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00818009011381 K120212 000

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