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510(k) Data Aggregation

    K Number
    K243638
    Device Name
    MV Flow Aspiration Pump (MVFLOWPMP01)
    Manufacturer
    MicroVention
    Date Cleared
    2025-06-13

    (200 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MV Flow Aspiration Pump is intended for general suction use in hospitals or clinics.
    Device Description
    The MV Flow Aspiration Pump is an electrically powered (100 VAC/50 Hz, 240 VAC/60 Hz) device designed to generate vacuum pressure and serve as the vacuum source intended for general suction use in hospitals or clinics. The MV Flow Aspiration Pump is not intended for use in transport or field settings. The pump delivers 29 inHg of maximum vacuum pressure with a maximum flow rate of 36 L/min. The power button and vacuum-relief button provide pressure control. The brushless DC, dual-diaphragm pump design includes reverse-flow protection. Compatible pump accessories, supplied separately, include the MV Flow Canister. The MV Flow Canister consists of a single-use collection canister with integrated bacteria filter, overflow protection, and a pre-installed intermediate tubing.
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    K Number
    K251111
    Device Name
    Cary
    Manufacturer
    Excitus AS
    Date Cleared
    2025-05-07

    (26 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
    Device Description
    [Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
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    K Number
    K243418
    Device Name
    Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing
    Manufacturer
    Micro Therapeutics Inc. d/b/a ev3 Neurovascular
    Date Cleared
    2024-12-02

    (28 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Riptide™ Aspiration Pump is intended as a vacuum source for Medtronic aspiration devices or systems for use in hospitals or clinics. Refer to the Instructions for Use included with the accessory aspiration device for indications related to the procedure for which this device will be used.
    Device Description
    The Riptide™ Aspiration Pump is an externally powered electromechanical device capable of generating a vacuum designed for drawing fluids and thrombus into the Riptide™ Collection Canister during interventional procedures. It is intended for general suction use in hospitals or clinics and is not intended for transport or field applications. The Riptide™ Aspiration Pump includes a receptacle that holds the Riptide™ Collection Canister with Intermediate Tubing in place. The intermediate tubing is connected to the vacuum inlet port. The Riptide™ Aspiration Pump package includes the following: - Riptide™ Aspiration Pump (LMT-RAP) - Region specific power cord for connection to earthed receptacle. - Riptide™ Aspiration Pump User's Manual The following item is required for use with Riptide™ Aspiration Pump (packaged separately): - Riptide™ Collection Canister with Intermediate Tubing (LMT-RCT) The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single use. The Riptide™ Collection Canister is the repository for aspirated material. The Riptide™ Canister is placed into the receptacle of the Riptide™ Aspiration Pump as shown in Figure 3. The Intermediate Tubing is then connected to the vacuum inlet port.
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    K Number
    K233428
    Device Name
    Easycess Aspiration Pump
    Manufacturer
    Guangzhou Easycess Medical Co., Ltd
    Date Cleared
    2023-11-03

    (23 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics.
    Device Description
    The Easycess Aspiration Pump is mainly composed of negative pressure suction pump host and Easycess Canister(Model: DC1000). The Easycess Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in 110V and 220Vac versions. The pump is used with the available 1000ml canister / tubing set. The Easycess Aspiration Pump is provided in non-sterile; it is reusable and should be managed as a prescription device. The Easycess Canister is for single use only.
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    K Number
    K222552
    Device Name
    120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
    Manufacturer
    Stryker Instruments
    Date Cleared
    2022-12-09

    (108 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neptune S Waste Management System is indicated for use in procedures where collecting and disposing of fluid waste and capturing suctioned tissue specimens is desired. It is intended to be used in operating rooms, pathology, surgical centers, procedure rooms, and for endoscopic procedures, such as colonoscopies, esophagogastroduodenoscopies (EGDs), and bronchoscopies.
    Device Description
    The Neptune S Waste Management System includes subject devices Neptune S Rover and V2 Manifolds, previously 510k cleared Neptune 2 Docker, and supporting accessories. Neptune S Rover is a mobile device, plugged into a standard 15A hospital-grade AC power outlet and is used to suction and collect waste fluids during surgical or nonsurgical procedures. It can also be used to collect tissue specimens suctioned during these procedures. The Rover provides fluid waste management, fluid volume measurement and contains features designed to specifically aid with tissue specimen collection, including an array of lighting features and a flat worksurface. It was designed with a smaller footprint to accommodate smaller operating rooms or procedure rooms, particularly endoscopy suites. The manifolds are non-sterile, single-use disposables, that act as an interface between the Rover canister and standard medical grade suction tubing. They facilitate the collection of surgical tissue and the removal of fluid waste.
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    K Number
    K182950
    Device Name
    Acare Suction Unit
    Manufacturer
    Acare Technology Co., Ltd.
    Date Cleared
    2019-08-23

    (304 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.
    Device Description
    The Acare Suction Unit, model ASU-200 is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. The device is a rugged, compact and portable electrically-operated medical suction device, designed for multi-source powering from AC (External 100V- 240 V) or DC (External 12V DC) mains supply or internal rechargeable battery, and is ideally suited for field, transport and hospital/clinical use applications. The Acare canister is an accessory to the Acare Pump and the removed body fluids are collected in it. The Acare Pump is an AC powered oil-less positive displacement pump capable of delivering up to 600 mmHg of vacuum to draw fluid and small particles. The Acare Pump has a plastic casing fitted with a power (ON/OFF) button, power indicator, one suction adjustment knob, a suction gauge and a canister holder. The Acare canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The Acare canister should be placed in the in-built canister holder and connect the Acare canister with the Acare Pump via the connectors of the canister tubing prior to use.
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    K Number
    K190789
    Device Name
    IntelliCartTM System
    Manufacturer
    Dornoch Medical Systems
    Date Cleared
    2019-04-24

    (28 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntelliCartTM System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
    Device Description
    The IntelliCart™ System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospitals, pathology labs, surgical outpatient centers, and doctor's offices. The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac). Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste. Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available. The IntelliCart™ System is a closed self-powered suction device providing various levels of suction, as selected by the user, ranging from 0-600 mmHg at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments.
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    K Number
    K190105
    Device Name
    ZOOM Aspiration Pump
    Manufacturer
    Taiwan Biomaterial Co., Ltd.
    Date Cleared
    2019-02-21

    (30 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZOOM Aspiration Pump The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics. ZOOM Canister The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump. ZOOM Aspiration Tubing The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
    Device Description
    The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile. There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.
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    K Number
    K180115
    Device Name
    TWBM Pump
    Manufacturer
    Taiwan Biomaterial Co., Ltd.
    Date Cleared
    2018-07-24

    (189 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TWBM Pump is intended for general suction use in hospitals or clinics.
    Device Description
    The TWBM Pump is intended for general suction use in hospitals or clinics where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. The TWBM Canister is an accessory to the TWBM Pump and the removed body fluids are collected in it. The TWBM Pump is an AC powered oil-less positive displacement pump capable of delivering up to 29 inHg (737 mmHg) of vacuum to draw fluid and small particles. The TWBM Pump has a plastic casing fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and one sliding canister holder. The TWBM Canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The TWBM Canister should be placed in the in-built sliding canister holder, and connect the TWBM Canister with the TWBM Pump via the connectors of the canister tubing prior to use. Both, the TWBM Pump and the TWBM Canister, are provided non-sterile and are packaged separately.
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    K Number
    K181398
    Device Name
    DV-300 Aspirator
    Manufacturer
    Ding Hwa Co., Ltd.
    Date Cleared
    2018-07-23

    (55 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Product Code :

    JCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DV-300 is intended for general suction use in hospitals or clinics.
    Device Description
    The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection. The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock. The DV-300 must only be used on the order of a physician.
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