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510(k) Data Aggregation

    K Number
    K091135
    Device Name
    RUTTER SUPRA STOMAL STENTS
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-09-14

    (147 days)

    Product Code
    FWN
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rutler Supra Stomal Stent is indicated for the prevention and treatment of laryngeal and tracheal stenosis.
    Device Description
    Not Found
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    K Number
    K972317
    Device Name
    MONTGOMERY THYROPLASTY IMPLANT SYSTEM
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-09-18

    (90 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.
    Device Description
    The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instruments which are used for selection of implant size and for the surgical thyroplasty procedure. The Montgomery® Thyroplasty Implant is a one-piece device consisting of a threetiered base and an obtuse triangular top. It is provided in five sizes for males and five for females. The difference in size relates to the height of the triangular portion of the Implant. There is a single base size for all five male implants and a smaller base size for all five female implants. Accessories to the System include the sterile, single use Measuring Kits for selection of the correct implant size at the time of surgery, the Procedure Kit for determining the correct position of the Implant and marking the window in the thyroid cartilage, and various elevators, hooks, etc. which are provided to facilitate both the surgical procedure and the placement of the Implant.
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    K Number
    K972459
    Device Name
    RHINOCELL NASAL PACKINGS
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-08-04

    (34 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a nasal packing to treat epistaxis.
    Device Description
    RHINOCELL™ Nasal Packings are constructed of polyvinyl alcohol (PVA) sponge using a patented formula. The packings will expand as fluid is introduced, giving the surgeon time for accurate positioning. There is a variety of RHINOCELL™ shapes and sizes to choose from, both with and without integral airways. All RHINOCELL™ packings are sold sterile, ready to use.
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    K Number
    K972096
    Device Name
    BIVALVE NASAL SPLINT
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-15

    (41 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
    Device Description
    The Bivalve Nasal Splint, constructed of medical grade flouroplastic (i.e. Teflon®), is designed to provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splint is available in two sizes, standard and large, with two thicknesses (0.25mm and 0.50mm) for each size. The standard size is for routine use, while the large size can be be trimmed for individual applications. Both sizes feature a lengthwise slit facilitating placement and removal, and pre-formed suture holes for stabilizing the splint. The Bivalve Nasal Splint is supplied sterile, two splints per packages per box.
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    K Number
    K972078
    Device Name
    POST-STOP EPISTAXIS CATHETER
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-10

    (37 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. To be used for control of posterior nasal epistaxis. 2. To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.
    Device Description
    The Post-Stop™ Epistaxis Catheter is a single balloon catheter with integral suction catheter designed for control of posterior intra-nasal hemorrhaging. It can also be used as an inter-operative packing to aid in prevention of fluid aspiration. The balloon is designed to control bleeding in the posterior chamber. The multi-port suction/irrigator catheter can be used to keep the nasal area clear and to help prevent the catheter from clogging. An internal guide wire is included to help direct the catheter into the posterior chamber and is removed after catheter placement. The Post-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.
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    K Number
    K972092
    Device Name
    NASAL AIRWAY SPLINT
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-08

    (34 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To maintain a nasal airway while providing septal support following surgery.
    Device Description
    The Nasal Airway Splint is designed provide septal support and allow nasal breathing post-operatively through the integral airway. The splints can be sutured through the preformed holes in the anterior tips for stabilization. The Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.
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    K Number
    K972151
    Device Name
    DOYLE COMBO NASAL AIRWAY SPLINT
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-07

    (28 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To maintain a nasal airway while providing septal support following surgery.
    Device Description
    The Doyle Combo Nasal Airway Splint is designed to provide septal support and allow nasal breathing post-operatively through the integral airway. The patented design features an expandable PVA sponge layer for added comfort and stabilization. For additional security, the splints can be sutured through the pre-formed holes in the anterior tips. The Doyle Combo Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.
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    K Number
    K972060
    Device Name
    NASAL SEPTAL BUTTON
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-03

    (31 days)

    Product Code
    LFB
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for non-surgical closure of nasal perforations.
    Device Description
    The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.
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    K Number
    K972082
    Device Name
    CUSTOM NASAL SPLINT
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-03

    (29 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
    Device Description
    The Custom Nasal Splints, constructed of medical grade flouroplastic (i.e. Teflor®) or medical grade silicone, are designed to be trimmed by the surgeon for custom applications. The splints provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splints are available in various thicknesses. The Custom Nasal Splint are supplied sterile, two splints per package, five packages per box.
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    K Number
    K972076
    Device Name
    EPI-MAX EPISTAXIS CATHETER
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-06-26

    (23 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. To be used for control of anterior and posterior nasal epistaxis. 2. To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
    Device Description
    The Epi-Max™ is a two-balloon catheter with integral airway designed for control of intra-nasal hemorrhage. The smaller balloon is designed to control bleeding in the posterior chamber, while the larger balloon controls bleeding in the anterior chamber. As a packing, it can be used following septoplasty, rhinoplasty, and other intra-nasal surgical procedures. The Epi-Max™ is supplied sterile and includes a 20cc syringe for balloon inflation.
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