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510(k) Data Aggregation
K Number
K990276Device Name
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1999-10-01
(246 days)
Product Code
KRJ
Regulation Number
870.4280Why did this record match?
Product Code :
KRJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass.
- The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed
- The device is intended for adult population only. .
Device Description
DPB30 Disposable Pre-bypass Filter
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K Number
K982385Device Name
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1999-02-01
(207 days)
Product Code
KRJ, NOV
Regulation Number
870.4280Why did this record match?
Product Code :
KRJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
- THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.
Device Description
Not Found
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