Panels › Cardiovascular › Product code DWF · Class 2
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation 870.4210
8510(k)s in 12 months (403 all time)
20recalls in 12 months (563 all time)
544recalls that name a 510(k)
Top companies in DWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular | 0 | 184 |
| Terumo Cardiovascular Systems Corp. | 10 | 143 |
| Medtronic Perfusion Systems | 12 | 77 |
| Sorin Group USA, Inc. | 0 | 47 |
| Edwards Lifesciences | 19 | 21 |
| Medtronic, Inc. | 31 | 1 |
| Dlp, Inc. | 22 | 0 |
| 3M Health Care, Sarns | 21 | 0 |
| Shiley, Inc. | 21 | 0 |
| Edwards Lifesciences Research Medical | 4 | 13 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog number 5580. Terminated |
DWF | K925442 |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, malleable stylet, ribbed balloon; catalog number 5579. Terminated |
DWF | K925442 |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, steerable stylet, ribbed balloon; catalog number 5578. Terminated |
DWF | K925442 |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, malleable stylet, ribbed balloon; catalog number 4430. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, malleable stylet, ribbed balloon, temperature monitor; catalog number 4429. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, steerable stylet, ribbed balloon; catalog number 4428. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual -inflate, 17 Fr, guidewire stylet, ribbed balloon; catalog number 4427. Terminated |
DWF | None listed |
| Jan 9, 2004 | Heartport Inc Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc 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 EndoC Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc 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 EndoCla Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduct Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduct Terminated |
DWF | K955121 K971291 +4 |
| Jul 22, 2003 | Quest Medical, Inc Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes Terminated |
DWF | K953838 |
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