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510(k) Data Aggregation
K Number
K161815Device Name
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2016-10-12
(103 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Device Description
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are fully flexible annular rings and bands designed to reduce and stabilize the valve annulus in patients undergoing mitral or tricuspid repair.
The rings and bands are made of braided polyester fabric. The ring and band contain a circumferential flexible radiopaque marker. The internal radiopaque marker provides radiographic visualization along the entire circumference.
The rings and bands are available in nine sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm, 36 mm, 38 mm and 40 mm. The size refers to the inner circumference between the green suture markers nearest the anterior location of the ring and band. FlexForm™ Sizers, Model FRBS, are used to determine the correct size of the ring or band.
The differences between the ring and band are as follows: The FlexForm™ Ring is a complete annular ring. Five markers are provided on the ring; two markers indicate the approximate location of the trigones; three additional markers are provided as an aid to suture placement in the posterior section.
The FlexForm™ Band is a partial ring, without an anterior segment. The key dimensions are the same as the FlexForm Annuloplasty Ring, except for the absence of the anterior segment. Five markers are provided on the band; two markers indicate the approximate location of the trigones; three markers are provided as an aid to suture placement in the posterior section.
The choice of ring or band is based on surgeon preference.
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K Number
K093903Device Name
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2010-07-15
(205 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for use in those patients undergoing surgery of diseased or damaged tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty Rings provide support for the tricuspid annulus and restrict expansion of the annulus.
Device Description
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are implantable, semi-rigid, annular Rings. The Rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a close-coiled MP35N spring. The two ends of the stiffener wire are fitted with miniature MP35N end caps at each trigone. These caps prevent the stiffener wire from poking through the end seam of the ring. The entire circumferential of the annuloplasty ring is radiopaque between trigones. The Rings are available in the following six sizes: 26mm, 28mm, 30mm, 32mm, 34mm, 36mm. The size refers to the inner major diameter of the ring.
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K Number
K090428Device Name
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2009-05-07
(77 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Device Description
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are implantable, adjustable flexible, annular bands (Figure II.1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of tubular braided Polyester. The band contains circumferential flexible radiopaque markers. The entire circumference of the band is radiopaque.
The bands are available in the following six sizes: 25 mm, 27 mm, 29 mm, 31 mm, 33 mm, 35 mm, 37mm and 39mm. The size refers to the equivalent inner circumference of the band, trigone to trigone.
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K Number
K083683Device Name
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2009-02-25
(75 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K072655Device Name
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2007-10-23
(33 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral annulus and restrict expansion of the annulus.
Device Description
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are implantable, Semi-Rigid, annular rings. The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a closecoiled MP35N spring, the two ends of which are joined together by a miniature MP35N coupler in the mid-anterior segment. The entire circumferential of the annuloplasty ring is radiopaque. The rings are available in the following six sizes: 24mm, 26mm, 28mm, 30mm, 32mm, 36mm, 36mm and 40mm. The size refers to the lateral diameter of the stiffener band.
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K Number
K071214Device Name
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2007-07-31
(91 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Device Description
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are implantable, adjustable flexible, annular rings (Figure II.1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of tubular braided Polyester. The ring contains circumferential flexible radiopaque markers. The entire circumference of the ring is radiopaque. The rings are available in the following six sizes: 25 mm, 27 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner circumference of the ring, trigone to trigone.
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K Number
K052565Device Name
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2005-11-17
(59 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Device Description
The ATS SIMULUS Annuloplasty Rings are implantable, fully flexible, annular rings (Figure 1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of braided Polyester. The ring contains a circumferential flexible radiopaque marker. The entire circumference of the ring is radiopaque. The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle. The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.
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K Number
K052899Device Name
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
Manufacturer
Genesee BioMedical, Inc.
Date Cleared
2005-11-17
(34 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee BioMedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS SIMULUS FC Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Device Description
The ATS SIMULUS FC Annuloplasty Bands are implantable, fully flexible, annular bands (Figure 1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of braided Polyester. The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque.
The annuloplasty bands and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle.
The bands are available in the following sizes: 23 mm, 27 mm, 29 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the band. Green trigone markers are spaced at 120° from the midpoint of the posterior segment, which is also indicated by a green marker.
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