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510(k) Data Aggregation
K Number
K122306Device Name
SYNOVIS COLLAGEN MATRIX (TBD)
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2013-03-08
(219 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.
Device Description
Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.
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K Number
K083039Device Name
VERITAS COLLAGEN MATRIX (DRY)
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2008-11-26
(43 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Veritas Collagen Matrix (Dry) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures.
Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.
Device Description
Veritas Collagen Matrix is an implantable surgical mesh comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is procured in the United States from cattle less than 30 months of age.
Veritas Collagen Matrix allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.
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K Number
K062915Device Name
VERITAS COLLAGEN MATRIX
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2006-12-06
(70 days)
Product Code
FTM, OXB, OXE, PAJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).
Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
Device Description
An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
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K Number
K041669Device Name
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2004-10-27
(128 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Device Description
Veritas Dry is intended to be used as a staple line buttress. Veritas Dry is composed of dehydrated non-crosslinked bovine pericardium, to facilitate easy loading of the pericardium strips onto the stapler forks, an anvil and a cartridge strip are secured in a mounting unit. One mounting unit is used for each stapler firing. Each Veritas Dry unit is provided sterile in a double pouch.
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K Number
K040415Device Name
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2004-04-14
(56 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Peri-Strips is intended to be used for reinforcement of suturelines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Device Description
An implantable surgical patch comprised of crosslinked bovine pericardium
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K Number
K040119Device Name
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2004-03-17
(57 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Device Description
An implantable surgical patch comprised of crosslinked bovine pericardium
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K Number
K040001Device Name
STEERABLE STYLET
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2004-03-09
(67 days)
Product Code
DRB
Regulation Number
870.1380Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.
Device Description
The Steerable Stylet is a sterile, single-use, disposable implantation tool which assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation.
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K Number
K030879Device Name
VERITAS COLLAGEN MATRIX
Manufacturer
SYNOVIS SURGICAL INNOVATIONS
Date Cleared
2003-04-24
(35 days)
Product Code
OXE, FTM, OWV, OXB, PAJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SYNOVIS SURGICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:
> Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus.
> Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
> Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).
Device Description
An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
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