Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K160695
    Device Name
    Talymed Suspension
    Manufacturer
    Marine Polymer Technologies, Inc.
    Date Cleared
    2016-12-06

    (267 days)

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

    Marine Polymer Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K111524
    Device Name
    MP 719
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2011-07-22

    (50 days)

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

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MP 719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries. MP719 is intended for use under the direction of a healthcare professional.
    Device Description
    MP 719 is a sterile, resorbable, non-woven membrane material comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae, intended for use in the management of bleeding. MP 719 is available in a range of sizes from 4cm x 4cm to 10cm x 10cm.
    Ask a Question
    K Number
    K082703
    Device Name
    MRDH BANDAGE
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2008-10-14

    (28 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    mRDH Bandage™ is a trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries.
    Device Description
    mRDH Bandage " is a soft. white, sterile non-woven lyophilized pad of a cellulosic polymer isolated from microalgae (poly-N-acetylglucosamine). It is attached to x-ray detectable gauze and packaged in a sterile blister pack. mRDH Bandage" is available as a 4in x 4in (10cm x 10cm) bandage.
    Ask a Question
    K Number
    K070557
    Device Name
    MP 719
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2007-05-23

    (85 days)

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

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TALIDERM™ is intended for use under the direction of a healthcare professional. TALIDERM™ is indicated for the management of wounds including: Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.
    Device Description
    TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.
    Ask a Question
    K Number
    K053300
    Device Name
    SYVEKEXCEL
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2006-03-28

    (123 days)

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

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
    Device Description
    Syvekexed® Vascular Access Hemostasis System consists of four (4) components in a kit: - 1. a Syvekexcel® Patch 3 cm x 4cm lyophilized pad of poly-N-acetylglucosamine with foam backing, - a disposable Polypropylene support structure, which snaps on to component 3, 2. - 3. a reusable Plexiglas handle, and - 4. a Tegaderm® transparent adhesive bandage Syvekexcel® Vascular Access Hemostasis System is used to apply direct pressure to obtain and maintain hemostasis, in a similar fashion to direct manual pressure on the access site or at a pressure point. After hemostasis has been achieved the Syvekexcel® Patch is covered with the Tegaderm transparent adhesive bandage.
    Ask a Question
    K Number
    K002550
    Device Name
    RDH BANDAGE
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    2000-12-20

    (125 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K984177
    Device Name
    MODIFICATION TO SKVEKPATCH
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    1998-12-18

    (28 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds. SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.
    Device Description
    Not Found
    Ask a Question
    K Number
    K972914
    Device Name
    SYVEK PATCH
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    1997-12-22

    (137 days)

    Product Code
    KGX
    Regulation Number
    880.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARINE POLYMER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1