SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring

Ring, Annuloplasty

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Simuplus Flexible Annuloplasty Ring, Simuplus Flexible Annuloplasty Band, Simuform Semi-rigid Annuloplasty Ring.

Pre-market Notification Details

Device IDK201449
510k NumberK201449
Device Name:SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
ClassificationRing, Annuloplasty
Applicant Medtronic, Inc. 1851 E. Deere Ave. Santa Ana,  CA  92705
ContactLisa Corbin
CorrespondentLisa Corbin
Medtronic, Inc. 1851 E. Deere Ave. Santa Ana,  CA  92705
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-07-01

NIH GUDID Devices

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