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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K994243
Device Name DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
Applicant
Heartport, Inc.
700 Bay Rd.
Redwood City,  CA  94063
Applicant Contact MARIANNE C DRENNAN
Correspondent
Heartport, Inc.
700 Bay Rd.
Redwood City,  CA  94063
Correspondent Contact MARIANNE C DRENNAN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/16/1999
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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