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510(k) Data Aggregation

    K Number
    K202325
    Device Name
    EasyPoint Blood Collection Plus
    Manufacturer
    Retractable Technologies, Inc.
    Date Cleared
    2021-04-09

    (235 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Retractable Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.
    Device Description
    The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle. The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.
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    K Number
    K133635
    Device Name
    EASYPOINT NEEDLE
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2014-06-17

    (203 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy Point™ Needle is intended for use with syringes for general purpose fluid injection and/or aspiration, and venipuncture to obtain blood collection. The EasyPoint™ Needle aids in the prevention of needlestick injuries.
    Device Description
    The EasyPoint™ Needle is intended for general purpose percutaneous injection or aspiration of fluids and venipuncture to obtain blood collection. The device contains a sharps injury prevention feature (needlestick prevention feature-chamber) that covers the entire needle after use. Initially available in sizes of 23G and 25G x 1" and 25G x 5/8" for use with 3mL syringes or smaller.
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    K Number
    K122355
    Device Name
    VANISHPOINT BLOOD COLLECTION SET
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2013-08-23

    (385 days)

    Product Code
    JKA, FPA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.
    Device Description
    The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" length needles and gauge sizes of 19, 21, 23 and 25.
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    K Number
    K112512
    Device Name
    VANISHPOINT BLOOD COLLECTION SET
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2011-10-20

    (51 days)

    Product Code
    FPA, JKA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.
    Device Description
    The VanishPoint® Blood Collection Set is designed to collect blood specimens from patients. The VanishPoint® Blood Collection Set aids in the prevention of needlestick injuries through its retraction mechanism. The device will initially be available with either 7" or 12" tubing, ¾" length needles and gauge sizes of 19, 21, 23 and 25.
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    K Number
    K101708
    Device Name
    PATIENT SAFE LUER CAP
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2011-02-24

    (252 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Patient Safe® Luer Cap is to cover male luer fittings (luer lock and luer slip), to reduce the risk of touch contamination and medication leakage.
    Device Description
    The Patient Safe® Luer Cap is for use on luer tips of other devices to prevent leakage and contact and/or environment contamination during transport to patient area.
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    K Number
    K081420
    Device Name
    VANISHPOINT I.V. CATHETER
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2008-11-07

    (171 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.
    Device Description
    The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.
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    K Number
    K072654
    Device Name
    PATIENT SAFE SYRINGE
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2007-12-14

    (85 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Patient Safe Syringe™ is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.
    Device Description
    The Patient Safe Syringe™ is a 3 piece piston syringe consisting of a calibrated hollow barrel and a movable plunger with a plunger seal. One end of the barrel has a male connector (nozzle) which permits attachment to a female (hub). The collar on the luer end is slightly extended to protect and prevent contact contamination of the luer tip and is compatible with most luer fittings.
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    K Number
    K051355
    Device Name
    VANISHPOINT I.V. CATHETER
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    2005-09-23

    (122 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® I.V. Catheter aids in the prevention of needlestick injuries.
    Device Description
    Not Found
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    K Number
    K980069
    Device Name
    VANISHPOINT SYRINGE
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    1998-02-12

    (35 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
    Device Description
    The 1cc Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997 and the 1cc Allergy and Insulin Syringes were introduced in November 1997. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user.
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    K Number
    K973301
    Device Name
    ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Date Cleared
    1997-11-07

    (66 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETRACTABLE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected form accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
    Device Description
    The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997.
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