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510(k) Data Aggregation
K Number
K193663Device Name
FloPump 57mL Centrifugal Pump
Manufacturer
International Biophysics Corporation
Date Cleared
2021-03-10
(435 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
International Biophysics Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Device Description
The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.
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K Number
K170029Device Name
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
Manufacturer
INTERNATIONAL BIOPHYSICS CORPORATION
Date Cleared
2017-12-15
(345 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOPHYSICS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Device Description
The FloPump 32mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.
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K Number
K122480Device Name
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
Manufacturer
INTERNATIONAL BIOPHYSICS CORPORATION
Date Cleared
2013-03-27
(225 days)
Product Code
BYI
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOPHYSICS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.
Device Description
The International Biophysics Corporation HFCWO Vibratory Vest is comprised of a vest of synthetic polymer fabric with installed oscillating vibratory motors organized into six zones. It has three buckles and straps on the front and one over each shoulder that are used to provide the wearer with a snug and evenly-distributed fit. Additionally, there is an included charger for the batteries and a remote that is wired into the vest to adjust the intensity of the oscillation on the patient as necessary and as prescribed by a physician.
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