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Found 8 results
510(k) Data Aggregation
K Number
K032893Device Name
SHELHIGH NO-REACT BIOCUFF
Manufacturer
SHELHIGH, INC.
Date Cleared
2003-12-19
(93 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.
Device Description
The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.
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K Number
K023940Device Name
SHELHIGH BIORING
Manufacturer
SHELHIGH, INC.
Date Cleared
2003-06-04
(190 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve.
The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.
Device Description
The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.
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K Number
K982101Device Name
SHELHIGH NO-REACT DURA SHIELD
Manufacturer
SHELHIGH, INC.
Date Cleared
2000-05-02
(687 days)
Product Code
GXQ
Regulation Number
882.5910Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
Device Description
The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
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K Number
K991567Device Name
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
Manufacturer
SHELHIGH, INC.
Date Cleared
1999-07-14
(70 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inguinal, lumbar, and umbilical hernia.
Device Description
The Shelhigh No-React® Tissue repair patch/ UroPatch™ is made of glutaraldehyde fixed boyine pericardium. rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
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K Number
K982810Device Name
SHELHIGH NO-REACT VASCUPATCH
Manufacturer
SHELHIGH, INC.
Date Cleared
1998-10-28
(78 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For repair of carotid endarterectomy and vascular patch grafting.
Device Description
The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
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K Number
K981756Device Name
SHELHIGH NO-REACT PNEUMOPLEDGETS
Manufacturer
SHELHIGH, INC.
Date Cleared
1998-08-05
(79 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.
Device Description
The Shelhigh No-React® PneumoPledgets strips are glutaraldehyde fixed sheet of bovine pericardium. They are held on the stapler by a unique design of a loop on the anterior part of the PneumoPledgets. It holds the strip by inserting the pointed edge of the staple into the loop. The posterior part (if needed) is held by an "O" ring made of pericardium as well. The PneumoPledgets. strips are customized to fit all sizes and types of staples. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar.
The material exhibits good tensile strength, shrink temperature excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant.
Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
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K Number
K974914Device Name
SHELHIGH NO-REACT PERICARDIAL PATCHES
Manufacturer
SHELHIGH, INC.
Date Cleared
1998-06-03
(177 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as a patch for closure of the patient's pericardium after open heart surgery, The patch may be tailored during surgery to meet the surgeon's needs.
The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.
Device Description
The Shelhigh No-React® Pericardial patch is a glutaraldehyde fixed sheet of bovine pericardium, rinsed with the detoxification process No-React®. The device is provided sterile in benzyl alcohol solution. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
The material exhibits excellent biocompatibility. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldhyde processed bovine pericardium has a long history of success as a permanently implanted material.
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K Number
K964467Device Name
SHELHIGH PERICARDIAL PATCH
Manufacturer
SHELHIGH, INC.
Date Cleared
1997-09-23
(320 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
SHELHIGH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.
Device Description
Not Found
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