Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K121748
    Device Name
    THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2012-07-27

    (43 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5 ml/sec at up to 300 psi fluid pressure.
    Device Description
    The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Guidewire, Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
    Ask a Question
    K Number
    K111417
    Device Name
    THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2011-07-15

    (56 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.
    Device Description
    The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Nitinol Guidewire. Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place the in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
    Ask a Question
    K Number
    K111138
    Device Name
    THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2011-06-22

    (61 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
    Device Description
    The PICC WAND® Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire. Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
    Ask a Question
    K Number
    K101422
    Device Name
    THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2011-03-22

    (306 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.
    Device Description
    The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but < 30 days) intravenous (IV) Catheter. The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to insert the IV Catheter. The IV Catheter may then be left in place for a period of < 30 days and used to sample blood and administer fluids intravenously. It can also be used to power inject contrast media up to a rate of 5 cc/sec. at a maximum of 300 psi fluid pressure. The Power WAND™ Safety Introducer with an Extended Dwell Catheter is provided "STERILE" by cthylene oxide gas and is labeled "Nonpyrogenic" and for "Single-Use". The device is composed of the following components: - Needle - Guidewire - Dilator - Extended Dwell IV Catheter The Power WAND™ Safety Introducer with an Extended Dwell Catheter accesses the target vessel using the Accelerated Scldinger Technique (AST). Once the IV Catheter is positioned within the target circulatory vessel the Needle/Guidewire/Dilator are removed from the patient as a single unit. The remaining indwelling single-lumen IV Catheter is used to sample blood and administer fluids intravenously for a time period of < 30 days. It can also be used to power inject contrast media up to a rate of 5 cc/sec at a maximum fluid pressure of 300 psi. A catheter stabilization device, Statl.ock IV Ultra®, is provided as an accessory to securely anchor the IV Catheter in place during use.
    Ask a Question
    K Number
    K101150
    Device Name
    PICC WAND PEELABLE SAFETY INTRODUCER
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2010-08-13

    (112 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
    Device Description
    The PICC WAND™ Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire, Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
    Ask a Question
    K Number
    K093022
    Device Name
    THE PICC WAND PEELABLE SAFETY INTRODUCER
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2010-01-20

    (113 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
    Device Description
    The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
    Ask a Question
    K Number
    K090372
    Device Name
    THE WAND MICROACCESS SAFETY INTRODUCER
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2009-03-30

    (45 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
    Device Description
    The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
    Ask a Question
    K Number
    K081697
    Device Name
    THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
    Manufacturer
    ACCESS SCIENTIFIC, INC.
    Date Cleared
    2008-12-04

    (170 days)

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

    ACCESS SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.
    Device Description
    The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
    Ask a Question

    Page 1 of 1