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510(k) Data Aggregation

    K Number
    K241583
    Device Name
    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2024-08-30

    (88 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remington Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature. VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger: The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications: - Intraoperative (Microvascular and Vascular) - Intraoperative Neurological - Transrectal and Peripheral Vascular.
    Device Description
    VascuChek® Surgical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. VascuChek® Clinical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. The VascuChek® device follows Track 1. A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K211589
    Device Name
    VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2022-01-27

    (248 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remington Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remington Medical, Inc. VascuChek™ device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications: - · Intraoperative (Microvascular and Vascular) - · Intraoperative Neurological - · Transrectal and Peripheral Vascular
    Device Description
    VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. The VascuChek™ device follows Track 1. A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K212065
    Device Name
    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2021-10-07

    (97 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remington Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
    Device Description
    VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver. The VascuChek™ device follows Track 1. A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K191315
    Device Name
    Remington Medical, Inc. Automatic Cutting Needle (NAC)
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2019-07-12

    (58 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remington Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
    Device Description
    The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used for obtaining biopsies from soft tissues such as liver, kidnev, prostate, spleen, lymph nodes and various soft tissue tumors in combination with compatible commercial biopsy instrument(s)/gun(s) which are FDA cleared and distributed in the US Market. The Automatic Cutting Needles (NAC) are available in five qauges (differentiated by color) and seven needle lengths. The Automatic Cutting Needle (NAC) is advanced via the compatible commercial biopsy instrument/gun into the desired tissue to obtain a sample for histological examination. The Automatic Cutting Needle (NAC) is a sterile, single patient use and non-pyrogenic device.
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    K Number
    K150266
    Device Name
    Remington Medical Inc. Tuohy Epidural Needles
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    2015-06-04

    (120 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMINGTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
    Device Description
    The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics. Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath. Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits).
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    K Number
    K130282
    Device Name
    REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    2013-05-13

    (97 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMINGTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.
    Device Description
    The Remington Medical (RMI) CentreFire 22 Biopsy Instrument is a semi-automatic, reusable, spring-loaded mechanical device that is designed to be used with Remington Medical NAC Biopsy Needles to obtain core biopsy samples from the prostate.
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    K Number
    K050884
    Device Name
    ADAPTER CABLE
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    2005-05-19

    (42 days)

    Product Code
    DTA
    Regulation Number
    870.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMINGTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
    Device Description
    The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil.
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    K Number
    K040266
    Device Name
    CORE NEEDLE BIOPSY
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    2004-07-09

    (155 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMINGTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.
    Device Description
    Remington CentreFire Biopsy Instrument
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    K Number
    K990428
    Device Name
    DRAINAGE BAG
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    1999-08-12

    (182 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMINGTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.
    Device Description
    Drainage Bag
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    K Number
    K983621
    Device Name
    NEEDLE GUIDE
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    1998-11-03

    (19 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMINGTON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Needle Guides shall be single use only and are to be used by a mammographic x-ray specialist in a healthcare setting to aid in needle placement.
    Device Description
    Needle Guide
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