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510(k) Data Aggregation
K Number
K221919Device Name
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
Manufacturer
Hemodia SAS
Date Cleared
2023-03-09
(251 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Hemodia SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
Device Description
The DOUBLEFLO INFLOW/OUTFLOW PUMP is a micro-processor controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various accessories / shaver systems. The pump has to be used with the following tube sets: DOUBLEFLO DAY TUBE SET, DOUBLEFLO PATIENT TUBE SET, DOUBLEFLO INFLOW TUBE SET, DOUBLEFLO OUTFLOW TUBE SET.
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K Number
K203480Device Name
DOUBLEFLO system
Manufacturer
Hemodia SAS
Date Cleared
2021-04-05
(129 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Hemodia SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
Device Description
The DOUBLEFLO system (pump) contains as a main component a microprocessor-controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems. The pump has to be used with the following tube sets: DAY TUBE Set, Patient Tube Set, Inflow Tube Set, Outflow Tube Set.
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K Number
K192921Device Name
Zeos Aqua Vision Pump and tube
Manufacturer
Hemodia SAS
Date Cleared
2020-10-09
(359 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Hemodia SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.
Device Description
The ZEOS AQUA VISION pump is a micro-processor controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems.
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