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510(k) Data Aggregation
K Number
K982755Device Name
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
Manufacturer
MEDTRONIC BLOOD MANAGEMENT
Date Cleared
1998-08-20
(52 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC BLOOD MANAGEMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and . Neurosurgical
- . Postoperative treatment areas
Device Description
The autoLog Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient.
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K Number
K981815Device Name
HEPTRAC ELECTRONIC QUALITY CONTROL
Manufacturer
MEDTRONIC BLOOD MANAGEMENT
Date Cleared
1998-07-30
(69 days)
Product Code
JPA
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC BLOOD MANAGEMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.
Device Description
The HEPtrac is an electronic control that has been developed to assist users of the Hepcon Hemostasis Management (HMS) Instrument (K894317) and associated cartridges and controls (K894317), to perform control testing as required under 42CFR493.1253. Sec. ( c ) "for all automated coagulation testing systems, the laboratory must include two levels control each eight hours of operation and each time a change in reagents occurs". The HEPtrac, electronic quality control is designed to minimize the use of liquid based controls by providing the operator a means to determine the operating condition of the instrument.
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K Number
K972894Device Name
AUTOTRANSFUSION APPARTUS (AUTOLOG)
Manufacturer
MEDTRONIC BLOOD MANAGEMENT
Date Cleared
1998-04-27
(265 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC BLOOD MANAGEMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The autoLog™ is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following: General, Cardiovascular, . Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical Postoperative treatment areas
Device Description
The autoLog™ is an autotransfusion apparatys (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and ppst-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline are pumped to a transfer bag that may be reinfused to the patient.
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