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-
(1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm
(2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-T 39700 ECC Pack
Material:701062473R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC
Material:701056771R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge BEQ-TOP 38300 ADULT CPS QID
Material:701055862R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory
Material: 701055604R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-
(1) Material: 701055490R01 BEQ-TOP 15801 inch ECC Pack
(2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin
Material: 701055388R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk
Material: 701054874R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD
Material: 701054451R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack
Material:701054438R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack
Material: 701054389R02 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24202 ADULT ECC
Material: 701054295R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge:
(1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD
(2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material: Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up
Material: 701053906R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4
Material: 701053486R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 32200 ECC Pack
Material: 701053319R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD
Material: 701052461R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD
Material: 701051935R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5502 ECC Pack
Material:701051791R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8"
Material:701050859R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF
Material:701050647R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack
Material:701050228R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack
Material:701050177R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack
Material:701050175R02 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8"
Material:701050060R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8
Material:701049440R02 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3
Material:701049440R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack
Material:701049346R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack
Material:701048690R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32
Material:701047962R01 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric
Material:709000520 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC
Material: 709000518 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC
Material: 709000516 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack
Material:709000490 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25503 TMC with BB & QiD Pedi
Material:709000473 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3
Material: 709000460 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 48002 Bridge Kit
Material: 709000444 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 25502 1/4 Better Bladder
Material: 709000434 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4
Material: 709000430 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8
Material: 709000428 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 5220 UAB Hospital Accessory
Material: 709000426 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 57000 Rotaflow Pack
Material: 709000424 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack
Material: 709000417 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy
Material: 709000390 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack
Material: 709000385 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack
Material: 709000370 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack
Material: 709000368 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 8030 4 in High Flow Pigtail
Material: 709000366 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 5914 TCH Inch Change Kit
Material: 709000334 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit
Material: 709000280 Terminated |
DWF | K080592 |
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