FDA 510(k) Applications Submitted by HEARTPORT, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K955121 |
11/09/1995 |
HEARTPORT ENDOARTERIAL RETURN CANNUAL |
HEARTPORT, INC. |
| K955132 |
11/09/1995 |
HEARTPORT ENDOAORTIC CLAMP |
HEARTPORT, INC. |
| K961333 |
04/08/1996 |
HEARTPORT MULTIFIRE CLIP APPLIER |
HEARTPORT, INC. |
| K961334 |
04/08/1996 |
HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE |
HEARTPORT, INC. |
| K961463 |
04/17/1996 |
HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 |
HEARTPORT, INC. |
| K962366 |
06/19/1996 |
HEARTPORT CABLE BULLDOG CLAMP |
HEARTPORT, INC. |
| K964161 |
10/17/1996 |
HEARTPORT ENDOAORTIC CLAMP |
HEARTPORT, INC. |
| K964248 |
10/24/1996 |
HEARTPORT ENDOCORONARY SINUS CATHETR |
HEARTPORT, INC. |
| K970496 |
02/10/1997 |
HEARTPORT MAZE SYSTEM: CRYOPROBE SET |
HEARTPORT, INC. |
| K990772 |
03/09/1999 |
DIRECTFLOW ARTERIAL CANNULA |
HEARTPORT, INC. |
| K971291 |
04/07/1997 |
HEARTPORT ENDOARTERIAL RETURN CANNULA |
HEARTPORT, INC. |
| K981995 |
06/08/1998 |
QUICKDRAW VENOUS CANNULA |
HEARTPORT, INC. |
| K972570 |
07/10/1997 |
HEARTPORT INTRODUCER SHEATH |
HEARTPORT, INC. |
| K964302 |
10/29/1996 |
HEARTPORT THORACIC TROCAR |
HEARTPORT, INC. |
| K974175 |
11/06/1997 |
HEARTPORT ENDOAORTIC CLAMP CATHETER |
HEARTPORT, INC. |
| K994243 |
12/16/1999 |
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP |
HEARTPORT, INC. |
| K965051 |
12/18/1996 |
HEARTPORT NEEDLE TROCAR |
HEARTPORT, INC. |
| K974736 |
12/19/1997 |
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER |
HEARTPORT, INC. |
| K981009 |
03/18/1998 |
HEARTPORT ENDOPULMONARY VENT CATHETER |
HEARTPORT, INC. |
| K961245 |
04/01/1996 |
HEARTPORT ENDOPULMONARY VENT |
HEARTPORT, INC. |
| K961270 |
04/02/1996 |
HEARTPORT ENDOSINUS CATHETER |
HEARTPORT, INC. |
| K962510 |
06/27/1996 |
HEARTPORT ENDOAORTIC CLAMP |
HEARTPORT, INC. |
| K962835 |
07/22/1996 |
HEARTPORT ENDOVENOUS DRAINAGE CANNULA |
HEARTPORT, INC. |
| K962858 |
07/22/1996 |
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM |
HEARTPORT, INC. |
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