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) |
|---|---|---|---|
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack
Material: 709000266 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 53400 Adaption Pack
Material: 709000213 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8506 Transport Pack
Material: 709000146 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge
Material: 709000133 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 52360 Cardioplegia Pack
Material: 709000127 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack
Material:709000115 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack
Material:709000113 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 28903 Adult ECC Pack
Material: 709000093 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric
Material: 709000078 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P
Material: 709000072 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder
Material: 709000058 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4"
Material: 709000011 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack
Material: 709000006 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery
Material:709000004 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack
Material: 701068798 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 35503 SGD Pack
Material: 701068797 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK
Material: 701068395 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 3502 LVAD 1/4"
Material: 701068168 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 3501 LVAD/ 3/8"
Material: 701068008 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK
Material: 701067837 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 35503 SGD PACK
Material: 701067668 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE
Material: 701067577 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU
Material: 701067372 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC
Material: 701067350 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK
Material: 701067280 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK
Material: 701067203 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE
Material: 701066883 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy
Material:701066664 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED
Material:701066583 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA
Material:701066551 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P
Material:701066366 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 41302 PRIMING LINES BUMC
Material:701066291 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION
Material:701066097 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 46500 PRIME PACK
Material:701065823 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK
Material: 701065770 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 36504 ADULT ECC PACK
Material: 701065765 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack
Material: 701065620 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI
Material: 701065512 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO
Material: 701065510 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4"
Material: 701065504 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 41301 BUMC ECC PACK
Material: 701065209 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack
Material: 701065190 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID
Material: 701064992 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8069 Pediatric Pack
Material: 701064965 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC
Material: 701064867 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK
Material: 701064834 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P
Material: 701064831 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC
Material: 701064825 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK
Material:701064804 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24105 ECC PACK
Material:701064757 Terminated |
DWF | K080592 |
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