Heartport, Inc. - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heartport, Inc. Cardiovascular ✕
22 devices
Cleared
May 05, 2000
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT...
Cardiovascular
141d
Cleared
Apr 20, 1999
QUICKDRAW VENOUS CANNULA
Cardiovascular
316d
Cleared
Mar 23, 1999
DIRECTFLOW ARTERIAL CANNULA
Cardiovascular
14d
Cleared
Sep 04, 1998
HEARTPORT ENDOPULMONARY VENT CATHETER
Cardiovascular
170d
Cleared
Jul 15, 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
Cardiovascular
208d
Cleared
Dec 16, 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
Cardiovascular
40d
Cleared
Oct 01, 1997
HEARTPORT INTRODUCER SHEATH
Cardiovascular
83d
Cleared
Jun 17, 1997
HEARTPORT ENDOARTERIAL RETURN CANNULA
Cardiovascular
71d
Cleared
May 09, 1997
HEARTPORT THORACIC TROCAR
Cardiovascular
192d
Cleared
May 09, 1997
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
Cardiovascular
88d
Cleared
Apr 04, 1997
HEARTPORT ENDOAORTIC CLAMP
Cardiovascular
169d
Cleared
Mar 12, 1997
HEARTPORT NEEDLE TROCAR
Cardiovascular
84d