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510(k) Data Aggregation
K Number
K020529Device Name
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
Manufacturer
A-MED SYSTEMS, INC.
Date Cleared
2002-08-26
(188 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
A-MED SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A-Med Large Centrifugal Blood Pump is indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
Device Description
The A-Med Large Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
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K Number
K013393Device Name
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
Manufacturer
A-MED SYSTEMS, INC.
Date Cleared
2001-11-09
(25 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
A-MED SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
Device Description
The A-Med Heparin Coated Miniature Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
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K Number
K992592Device Name
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
Manufacturer
A-MED SYSTEMS, INC.
Date Cleared
2000-05-04
(276 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
A-MED SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A-Med Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc.). The A-Med Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
Device Description
The A-MED Miniature Centrifugal Pump is a sterile, disposable, non-roller pump which utilizes a rotor to impart energy to the blood through centrifugal forces. The flow of the miniature pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the miniature pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the miniature pump.
The A-MED Miniature Centrifugal Pump System includes a motor, ultrasonic flow sensor and a microcomputer-based control console which are available separately. The Miniature pump consists of inner and outer housings containing a rotor which imparts energy to the pumping fluid through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. The shaft of the rotor is constrained by two sets of bearings that allow it to rotate freely. A lip seal is used just behind the rotor to seal fluid from entering into the bearing area.
A sheath cable assembly connects the pump to the drive motor. The pump end of the cable has a square drive shaft that is bonded and crimped to the cable. This drive shaft fits into a square opening in the end of the rotor. The other end of the cable is connected to a magnet rotor housed in a plastic shell. This end is assembled onto the motor-stator for operation. By assembling the magnet rotor into the end of the cable-sheath assembly, hermitic sealing of the pumping chamber is obtained.
A priming port (valve) is provided on the housing to clear the pump of air before starting circulation. The port is designed to open when a syringe is inserted and seals when the syringe is removed.
The pump is designed to be placed in the sterile field and operated from the A-Med remote motor and microcomputer based blood pump controller, located outside the sterile field. The A-Med Centrifugal Pump System also includes an ultrasonic flow meter, manufactured by Transonics, Inc.
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K Number
K991541Device Name
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
Manufacturer
A-MED SYSTEMS, INC.
Date Cleared
1999-12-28
(239 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
A-MED SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A-Med Vascular Cannula is intended for use in accessing the circulatory system during extracorporeal circulation.
The A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system. (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.
Device Description
The A-Med Vascular Cannula is a cannula comprised of a flexible tip, radiopaque stripes, wire reinforced tubing, non-reinforced proximal clamp zone, and a proximal connector. Configurations are available with the following options:
- . Outer diameter: 24 French
- . Effective length: 10, 21 inch
- Number of holes in tip: 8, 16, 32, 44 (dependant on length) ●
- Proximal connector: barb, barb with side luer lock, quick connect ●
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