MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B

Ring, Annuloplasty

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Colvin-galloway Future Annuloplasty Band, Model 638b.

Pre-market Notification Details

Device IDK011395
510k NumberK011395
Device Name:MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
ClassificationRing, Annuloplasty
Applicant MEDTRONIC VASCULAR 8299 CENTRAL AVE., N.E. MAIL STOP: P108 Minneapolis,  MN  55432
ContactCharles Dowd
CorrespondentCharles Dowd
MEDTRONIC VASCULAR 8299 CENTRAL AVE., N.E. MAIL STOP: P108 Minneapolis,  MN  55432
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-07
Decision Date2001-07-12

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