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510(k) Data Aggregation
K Number
K991864Device Name
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
Manufacturer
JOSTRA MEDIZINTECHNIK AG
Date Cleared
2000-08-31
(457 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
JOSTRA MEDIZINTECHNIK AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Device Description
The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:
1. Components to be used in combination with the RotaFlow Console:
1.1 Hardware: RotaFlow Console RFC 20-970, RotaFlow Drive Unit RFD 20-973, RotaFlow Emergency Drive RFE 20-976
1.2 Disposable: RotaFlow Centrifugal Pump RF-32
2. Components to be used in combination with the Bio-Medicus Console:
2.1 Hardware: Magnet Adapter MA-32
2.2 Disposables: RotaFlow Centrifugal Pump RF-32F, External Flow Probe FP-32E
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K Number
K001787Device Name
QUART ARTERIAL FILTER, MODEL HBF 140
Manufacturer
JOSTRA MEDIZINTECHNIK AG
Date Cleared
2000-06-30
(17 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Applicant Name (Manufacturer) :
JOSTRA MEDIZINTECHNIK AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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