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510(k) Data Aggregation
K Number
K980534Device Name
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
Manufacturer
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
Date Cleared
1998-04-30
(78 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Duran Flexible Annuloplasty Ring is indicated for the reconstruction and/or remodeling of the pathologic mitral and tricuspid valves. Combined atrioventricular valve insufficiency and stenosis may be corrected by appropriate commissurotomy and valvular remodeling.
Device Description
The delivery system for the Duran Flexible Annuloplasty Ring consists of the ring holder, template and handle. The annuloplasty ring is mounted onto a rigid, colored plastic holder via sutures. The ring holder is connected to a rigid clear plastic template. The Duran Annuloplasty Ring and Delivery system is available in 25, 27, 29, 31, 33, and 35 mm sizes. A plastic colored handle is provided as part of the delivery system. The handle contains a wire portion for flexibility during use. The handle is provided to assist in the implantation of the assembly to the surgical site.
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K Number
K960356Device Name
POSTERIOR ANNULOPLASTY BAND (MODEL 607)
Manufacturer
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
Date Cleared
1996-08-27
(215 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is indicated for the reconstruction and/or remodeling of the pathological mitral valve. Combined mitral valve stenosis and insufficiency may be corrected by appropriate commissurotomy and valvular remodeling.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is contraindicated for use under the following conditions: the presence of heavy valvular calcification, valvular retraction with severely reduced mobility and the presence of active bacterial endocarditis.
Device Description
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is constructed of a polyester fabric enclosing an open strip of pliable radiopaque sillicone elastomer impregnated with barium sulfate which enables radiographic visualization. The band is uniformly 3 mm in diameter and is provided in a single length of 63 mm. Colored suture markers, which facilitate implantation, are circumferentially located at the center of the band and at each end.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be offered in one length, 63 mm and will not be mounted onto a holder. No sizers will be offered with the posterior band configuration as only one length is available.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be supplied in a sterile double aseptic transfer pouch. The annuloplasty band will remain sterile if the pouch is undamaged and unopened.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND uses the same materials and is processed, packaged and sterilized similarly to the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.
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