Medical Device Manufacturer · US , Redwood City , CA

Heartport, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1996
24
Total
24
Cleared
0
Denied

FDA 510(k) Regulatory Record - Heartport, Inc. Cardiovascular

22 devices
1-22 of 22
Cleared May 05, 2000
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT...
K994243 · DWF
Cardiovascular · 141d
Cleared Apr 20, 1999
QUICKDRAW VENOUS CANNULA
K981995 · DWF
Cardiovascular · 316d
Cleared Mar 23, 1999
DIRECTFLOW ARTERIAL CANNULA
K990772 · DWF
Cardiovascular · 14d
Cleared Sep 04, 1998
HEARTPORT ENDOPULMONARY VENT CATHETER
K981009 · DWF
Cardiovascular · 170d
Cleared Jul 15, 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
K974736 · DWF
Cardiovascular · 208d
Cleared Dec 16, 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · DWZ
Cardiovascular · 40d
Cleared Oct 01, 1997
HEARTPORT INTRODUCER SHEATH
K972570 · DYB
Cardiovascular · 83d
Cleared Jun 17, 1997
HEARTPORT ENDOARTERIAL RETURN CANNULA
K971291 · DWF
Cardiovascular · 71d
Cleared May 09, 1997
HEARTPORT THORACIC TROCAR
K964302 · DRC
Cardiovascular · 192d
Cleared May 09, 1997
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
K970496 · OCL
Cardiovascular · 88d
Cleared Apr 04, 1997
HEARTPORT ENDOAORTIC CLAMP
K964161 · DXC
Cardiovascular · 169d
Cleared Mar 12, 1997
HEARTPORT NEEDLE TROCAR
K965051 · DRC
Cardiovascular · 84d
Cleared Feb 10, 1997
HEARTPORT ENDOVENOUS DRAINAGE CANNULA
K962835 · DWF
Cardiovascular · 203d
Cleared Jan 22, 1997
HEARTPORT ENDOCORONARY SINUS CATHETR
K964248 · DWF
Cardiovascular · 90d
Cleared Nov 15, 1996
HEARTPORT MULTIFIRE CLIP APPLIER
K961333 · DSS
Cardiovascular · 221d
Cleared Nov 07, 1996
HEARTPORT CABLE BULLDOG CLAMP
K962366 · DXC
Cardiovascular · 141d
Cleared Sep 30, 1996
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG...
K962858 · DXC
Cardiovascular · 70d
Cleared Sep 11, 1996
HEARTPORT ENDOAORTIC CLAMP
K962510 · DXC
Cardiovascular · 76d
Cleared Jun 18, 1996
HEARTPORT ENDOPULMONARY VENT
K961245 · DWF
Cardiovascular · 78d
Cleared Jun 18, 1996
HEARTPORT ENDOSINUS CATHETER
K961270 · DWF
Cardiovascular · 77d
Cleared Jun 07, 1996
HEARTPORT ENDOAORTIC CLAMP
K955132 · DXC
Cardiovascular · 211d
Cleared May 10, 1996
HEARTPORT ENDOARTERIAL RETURN CANNUAL
K955121 · DWF
Cardiovascular · 183d
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