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510(k) Data Aggregation
K Number
K031323Device Name
DBT, DYNAMIC BUBBLE TRAP
Manufacturer
Date Cleared
2003-08-01
(98 days)
Product Code
Regulation Number
870.4260Why did this record match?
Applicant Name (Manufacturer) :
CONVERGENZA AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DBT™ is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.
Device Description
The DBT™, Dynamic Bubble Trap is a sterile device with a non-pyrogenic fluid pathway. It is intended for single use only, in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures. It is designed to remove gaseous microemboli from the arterial line of a cardiopulmonary bypass circuit.
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