Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K000004
    Device Name
    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
    Manufacturer
    DAIG CORP.
    Date Cleared
    2000-11-29

    (331 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994334
    Device Name
    ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
    Manufacturer
    DAIG CORP.
    Date Cleared
    2000-05-15

    (144 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
    Device Description
    The Daig Ultra-Flex Hemostasis Introducer is an Introducer designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.
    Ask a Question
    K Number
    K982299
    Device Name
    SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
    Manufacturer
    DAIG CORP.
    Date Cleared
    1998-10-19

    (110 days)

    Product Code
    DQO, DOO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daig SpyglassTM angiographic catheters are designed for delivery of radiopaque contrast media during angiographic procedures. The 5Fr Spyglass™ Angiographic Catheter is designed for delivery of radiopaque contrast media during angiographic procedures.
    Device Description
    Daig SpyglassTM angiographic catheters are radiopaque polymer reinforced with braided stainless steel. This construction yields a small diameter catheter, which retains strength and high flow rate capabilities. A soft atraumatic tip provides good memory and protects against vessel damage. Preformed tip shapes matching or complementing specific anatomy allow access into a variety of vessels.
    Ask a Question
    K Number
    K982187
    Device Name
    FAST-CATH INTRA-CARDIAC INTRODUCER
    Manufacturer
    DAIG CORP.
    Date Cleared
    1998-09-16

    (86 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fast-Cath™ Intra-Cardiac Introducer is intended for use when introducing various cardiovascular catheters or biopsy devices into the heart.
    Device Description
    The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction/exchange. A sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc.
    Ask a Question
    K Number
    K973840
    Device Name
    FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
    Manufacturer
    DAIG CORP.
    Date Cleared
    1998-05-21

    (225 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.
    Device Description
    The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.
    Ask a Question
    K Number
    K964518
    Device Name
    FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
    Manufacturer
    DAIG CORP.
    Date Cleared
    1997-05-14

    (201 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965249
    Device Name
    SPYGLASS ANGIOGRAPHIC CATHETER
    Manufacturer
    DAIG CORP.
    Date Cleared
    1997-02-21

    (71 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962805
    Device Name
    SPYGLASS ANGIOGRAPHIC CATHETER
    Manufacturer
    DAIG CORP.
    Date Cleared
    1996-10-15

    (89 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAIG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1