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510(k) Data Aggregation
K Number
K973760Device Name
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
Manufacturer
AVECOR CARDIOVASCULAR, INC.
Date Cleared
1998-02-18
(139 days)
Product Code
DTZ
Regulation Number
870.4350Why did this record match?
Applicant Name (Manufacturer) :
AVECOR CARDIOVASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Affinity™ Hollow Fiber Membrane Oxygenator Systems are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Device Description
Not Found
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K Number
K964017Device Name
AFFINITY BLOOD PUMP SYSTEM
Manufacturer
AVECOR CARDIOVASCULAR, INC.
Date Cleared
1997-08-05
(302 days)
Product Code
DTQ
Regulation Number
870.4220Why did this record match?
Applicant Name (Manufacturer) :
AVECOR CARDIOVASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Device Description
The AVECOR Cardiovascular Affinity Pump System consists of the Model 2000 Affinity Pump Console, Affinity Pump Rotor, Affinity Pump Holder, Affinity Pump Chamber, 5/8" Connecting Tube and an AVECOR venous reservoir with 5/8" outlet. The AVECOR Affinity Blood Pump Console and components' shall conform with all the applicable requirements of IEC 601, UL 544 and will display the European Community CE marking. The Affinity Pump Console, Model 2000 provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure, timed events and battery status. The AVECOR Affinity Pump has been designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyurethane chamber incorporating polycarbonate inlet and outlet connectors, which fills passively due to the filling pressure exhibited by the fluid height in a reservoir. The peristaltic action of the rollers against the filled pump chamber results in forward flow. Flow rate is affected by the combination of reservoir volume, RPM's of the pump rotor and the total circuit resistance.
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K Number
K971105Device Name
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
Manufacturer
AVECOR CARDIOVASCULAR, INC.
Date Cleared
1997-07-11
(107 days)
Product Code
DTN
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
AVECOR CARDIOVASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
Device Description
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardion in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
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