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K Number
K955038
Device Name
STOCKERT S3 DOUBLE HEAD PUMP MODULE
Manufacturer
STOECKERT INSTRUMENTE
Date Cleared
1996-02-21

(110 days)

Product Code
DWB
Regulation Number
870.4370
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.4370 Roller-type cardiopulmonary bypass blood pump.

(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).