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510(k) Data Aggregation

    K Number
    K002233
    Device Name
    BVI SLING
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    2000-10-13

    (81 days)

    Product Code
    PAJ
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992537
    Device Name
    PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    2000-02-22

    (208 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectorny, segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectorny, lobectomies, segmentectomies (segmental resections), wedge resections, bullectornies, blebectomias, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.
    Device Description
    Peri-Strips (sleeve and strip) and Peri-Strips Dry are surgical mesh patches derived from bovine pericardium that is cross-linked with glutaraldehyde. Peri-Strips comes in two configurations: Peri-Strips-sleeve and Peri-Strips-strip. Each unit of Peri-Strips-sleeve is composed of two strips of bovine pericardial tissue. After the final manufacturing step, each strip of pericardium is sewn to a polyolefin strip with polypropylene suture to create a tubular sleeve. The tubular configuration facilitates usage of the product with surgical staplers. The polyolefin strip and sutures are removed after the Peri-Strips-sleeve is secured in place. Peri-Strips-strip is a flat piece of bovine pericardium that is sutured to the stapler by the surgical team. For Peri-Strips Dry (PSD), the bovine pericardial patch is manufactured in the form of a strip and undergoes an additional manufacturing step of dehydration by vacuum drying. The strip is affixed to the surgical stapler with the aid of a hydrogel (PSD Gel) supplied with the product. Product may be treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20-25°C, rinsed with deionized (DI) water, and neutralized with citrate solution, followed by a final DI water rinse.
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    K Number
    K983602
    Device Name
    CV PERI-GUARD AND VASCU-GUARD
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-11-12

    (30 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing. Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions. Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
    Device Description
    CV Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
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    K Number
    K983581
    Device Name
    OCU-GUARD AND OCU-GUARD SUPPLE
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-11-06

    (24 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.
    Device Description
    Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
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    K Number
    K983162
    Device Name
    PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-10-09

    (29 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
    Device Description
    Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard® is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
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    K Number
    K981624
    Device Name
    FLO-THRU
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-08-04

    (89 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.
    Device Description
    The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS) is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the bulbs allow blood to flow through the shunt and distal to the anastomotic site. A radiopaque tab, which identifies the outer diameter of the bulbs, is attached to the shunt by a tether to facilitate positioning and removal of the shunt.
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    K Number
    K982282
    Device Name
    DURA-GUARD - DURAL REPAIR PATCH
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-07-30

    (30 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a dural substitute for the closure of dura mater during neurosurgery.
    Device Description
    Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.
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    K Number
    K971726
    Device Name
    CV PERI-GUARD - CARDIOVASCULAR PATCH
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1998-04-10

    (336 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CV Peri-Guard™ is intended for use as a patch for intracardiac, great vessel, valve repair and suture line buttressing (i.e. atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft buttress). May be used for repair of ventricular septal defect (VSD) using either a single patch or reinforced patch technique. May also be used in other applications exposed to peak systolic pressure using a reinforced patch technique (i.e. ventricular aneurysm patch, aortic graft suture line buttress). CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
    Device Description
    CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.
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    K Number
    K973706
    Device Name
    DURA-GUARD-DURAL REPAIR PATCH
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1997-12-24

    (86 days)

    Product Code
    GXQ, GXO
    Regulation Number
    882.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a dural substitute for the closure of dura mater during neurosurgery.
    Device Description
    Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.
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    K Number
    K973552
    Device Name
    OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1997-12-16

    (88 days)

    Product Code
    MTZ
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ocu-Guard™ and Supple Ocu-Guard™ are indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the Implant. Ocu-Guard and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.
    Device Description
    Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde. Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm. Ocu-Guard and Supple Ocu-Guard will also be available as a "pre-formed" wrap. The "pre-formed" wrap will be available in configurations which will fit implant spheres ranging from 14 mm to 22 mm in size.
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