BIFLEX(TM) ANNULOPLASTY RING

Ring, Annuloplasty

ST. JUDE MEDICAL, INC.

The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Biflex(tm) Annuloplasty Ring.

Pre-market Notification Details

Device IDK902159
510k NumberK902159
Device Name:BIFLEX(TM) ANNULOPLASTY RING
ClassificationRing, Annuloplasty
Applicant ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul,  MN  55117
ContactM Anderson
CorrespondentM Anderson
ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul,  MN  55117
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-15
Decision Date1991-01-18

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