FDA 510(k) Application Details - K990772

Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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510(K) Number K990772
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant HEARTPORT, INC.
700 BAY RD.
REDWOOD CITY, CA 94063 US
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Contact MARIANNE C DRENNAN
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Regulation Number 870.4210

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Classification Product Code DWF
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Date Received 03/09/1999
Decision Date 03/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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