POSTERIOR ANNULOPLASTY BAND (MODEL 607)

Ring, Annuloplasty

THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG

The following data is part of a premarket notification filed by The Heart Valve Div. Medtronic Cardiovascular Surg with the FDA for Posterior Annuloplasty Band (model 607).

Pre-market Notification Details

Device IDK960356
510k NumberK960356
Device Name:POSTERIOR ANNULOPLASTY BAND (MODEL 607)
ClassificationRing, Annuloplasty
Applicant THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 18011 SOUTH MITCHELL Irvine,  CA  92714
ContactKathleen T Boehm
CorrespondentKathleen T Boehm
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 18011 SOUTH MITCHELL Irvine,  CA  92714
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-25
Decision Date1996-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994759177 K960356 000
10681490268551 K960356 000

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