MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

Ring, Annuloplasty

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Contour 3d Annuloplasty Ring, Model 690r.

Pre-market Notification Details

Device IDK101212
510k NumberK101212
Device Name:MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
ClassificationRing, Annuloplasty
Applicant MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactBecky Hannack
CorrespondentBecky Hannack
MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-30
Decision Date2010-08-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994845375 K101212 000
00643169121683 K101212 000
00643169121690 K101212 000
00643169121706 K101212 000
00643169121713 K101212 000
00643169121720 K101212 000
00613994845320 K101212 000
00613994845337 K101212 000
00613994845344 K101212 000
00613994845351 K101212 000
00613994845368 K101212 000
00643169121676 K101212 000

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