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Found 9 results
510(k) Data Aggregation
K Number
K103347Device Name
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Manufacturer
INTERVASCULAR, SAS
Date Cleared
2011-02-02
(79 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Woven Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive diseases of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries . Due to the low porosity of Woven vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Device Description
Not Found
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K Number
K042984Device Name
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
Manufacturer
INTERVASCULAR
Date Cleared
2005-02-18
(112 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InterGard Woven Connector Graft is intended for use in arterial perfusion of the aorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.
Device Description
InterGard Woven Connector Graft
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K Number
K022242Device Name
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
Manufacturer
INTERVASCULAR
Date Cleared
2002-08-14
(34 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.
Device Description
The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.
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K Number
K013651Device Name
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
Manufacturer
INTERVASCULAR
Date Cleared
2002-02-27
(113 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterGard HemaBridge and InterGard Aortic Arch Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Device Description
Not Found
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K Number
K990800Device Name
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
Manufacturer
INTERVASCULAR, INC.
Date Cleared
2001-01-08
(670 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterGard Collagen Coated and Heparin Bonded vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Device Description
The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The InterGard Knitted Ultra-Thin, are Vascular Grafts made of Dacron fabric and coated with bovine collagen. These products are offered in numerous lengths and diameters exceeding 6 mm.
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K Number
K984294Device Name
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Manufacturer
INTERVASCULAR, INC.
Date Cleared
1999-02-22
(83 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Device Description
InterGard Woven Collagen Coated Vascular Prostheses
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K Number
K983819Device Name
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
Manufacturer
INTERVASCULAR, INC.
Date Cleared
1998-11-24
(26 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterGard Knitted Ultra Thin Vascular Graft
- InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
HemaCarotid Patch Ultra Thin
The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Device Description
InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches
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K Number
K970843Device Name
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Manufacturer
INTERVASCULAR, INC.
Date Cleared
1997-06-05
(90 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Device Description
InterGard™ Woven Collagen Coated Vascular Prostheses
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K Number
K964625Device Name
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
Manufacturer
INTERVASCULAR, INC.
Date Cleared
1997-05-05
(171 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
INTERVASCULAR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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