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Heartport, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT,May 5, 2000
K981995QUICKDRAW VENOUS CANNULAApril 20, 1999
K990772DIRECTFLOW ARTERIAL CANNULAMarch 23, 1999
K981009HEARTPORT ENDOPULMONARY VENT CATHETERSeptember 4, 1998
K974736HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCERJuly 15, 1998
K974175HEARTPORT ENDOAORTIC CLAMP CATHETERDecember 16, 1997
K972570HEARTPORT INTRODUCER SHEATHOctober 1, 1997
K971291HEARTPORT ENDOARTERIAL RETURN CANNULAJune 17, 1997
K964302HEARTPORT THORACIC TROCARMay 9, 1997
K970496HEARTPORT MAZE SYSTEM: CRYOPROBE SETMay 9, 1997
K964161HEARTPORT ENDOAORTIC CLAMPApril 4, 1997
K965051HEARTPORT NEEDLE TROCARMarch 12, 1997
K962835HEARTPORT ENDOVENOUS DRAINAGE CANNULAFebruary 10, 1997
K964248HEARTPORT ENDOCORONARY SINUS CATHETRJanuary 22, 1997
K961334HEARTPORT HANDSWITCH ELECTROCAUTERY PROBENovember 15, 1996
K961333HEARTPORT MULTIFIRE CLIP APPLIERNovember 15, 1996
K962366HEARTPORT CABLE BULLDOG CLAMPNovember 7, 1996
K961463HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2October 8, 1996
K962858HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRASeptember 30, 1996
K962510HEARTPORT ENDOAORTIC CLAMPSeptember 11, 1996