Heartport, Inc.
Redwood City, CA, US
Heartport, Inc. appears in FDA device records in Redwood City, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Heartport, Inc. between 1996 and 2000. The busiest year on record is 1996, with 10. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 10 |
| 1997 | 9 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP | DWF | Substantially Equivalent | |
| K981995 | QUICKDRAW VENOUS CANNULA | DWF | Substantially Equivalent | |
| K990772 | DIRECTFLOW ARTERIAL CANNULA | DWF | Substantially Equivalent | |
| K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER | DWF | Substantially Equivalent | |
| K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER | DWF | Substantially Equivalent | |
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER | DWZ | Substantially Equivalent | |
| K972570 | HEARTPORT INTRODUCER SHEATH | DYB | Substantially Equivalent | |
| K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA | DWF | Substantially Equivalent | |
| K970496 | HEARTPORT MAZE SYSTEM: CRYOPROBE SET | OCL | Substantially Equivalent | |
| K964302 | HEARTPORT THORACIC TROCAR | DRC | Substantially Equivalent | |
| K964161 | HEARTPORT ENDOAORTIC CLAMP | DXC | Substantially Equivalent | |
| K965051 | HEARTPORT NEEDLE TROCAR | DRC | Substantially Equivalent | |
| K962835 | HEARTPORT ENDOVENOUS DRAINAGE CANNULA | DWF | Substantially Equivalent | |
| K964248 | HEARTPORT ENDOCORONARY SINUS CATHETR | DWF | Substantially Equivalent | |
| K961334 | HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE | GEI | Substantially Equivalent | |
| K961333 | HEARTPORT MULTIFIRE CLIP APPLIER | DSS | Substantially Equivalent | |
| K962366 | HEARTPORT CABLE BULLDOG CLAMP | DXC | Substantially Equivalent | |
| K961463 | HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 | GCJ | Substantially Equivalent | |
| K962858 | HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM | DXC | Substantially Equivalent | |
| K962510 | HEARTPORT ENDOAORTIC CLAMP | DXC | Substantially Equivalent | |
| K961270 | HEARTPORT ENDOSINUS CATHETER | DWF | Substantially Equivalent | |
| K961245 | HEARTPORT ENDOPULMONARY VENT | DWF | Substantially Equivalent | |
| K955132 | HEARTPORT ENDOAORTIC CLAMP | DXC | Substantially Equivalent | |
| K955121 | HEARTPORT ENDOARTERIAL RETURN CANNUAL | DWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DXCClamp, Vascular
- DSSClip, Vascular
- DWZDevice, Biopsy, Endomyocardial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- DRCTrocar
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0811-05 | The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. | Guidewire is protruding through the film portion of the packages which compromises the sterility of the device. | Terminated | ||
| Z-0311-04 | Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. | Terminated | ||
| Z-0310-04 | SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24. | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. | Terminated | ||
| Z-0309-04 | DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as the ENDODIRECT System, Product codes ED241, 242, 243, 244. | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. | Terminated | ||
| Z-0308-04 | EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044). | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. | Terminated | ||
| Z-0307-04 | EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the ''EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232. | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain