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 30601 CMC ACCESSORY KIT
Material: 701064701 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY
Material: 701064590 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 5211 LARGE ECC SET
Material:701064560 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21506 ECC PACK
Material:701064505 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM
Material: 701063255 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC
Material: 701063149 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK
Material:701063071 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 40700 HUNTINGTON
Material:701062899 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT
Material:701062613 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 39700 ECC PACK
Material:701062473 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 26402 ECC PACK
Material: 701062310 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38900 ECC PACK
Material: 701056368 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK
Material: 701056041 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 8029 PRESSURE PIGTAIL 6"
Material: 701055995 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 8028 PRESSURE PIGTAIL 4"
Material: 701055993 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID
Material: 701055866 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID
Material: 701055862 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY
Material: Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID
Material: 701055601 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC
Material: 701055388 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK
Material: 701055372 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32
Material:701055142 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 22706 SAMPLE MANIFOLD
Material:701054912 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 13901 RAPID RESPONSE
Material:701054874 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP
Material:701054776 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC
Material:701054438 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24202 ADULT ECC
Material:701054295 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK
Material: 701054150 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25001 MONTEFIORE
Material: 701053906 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK
Material: 701053845 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK
Material: 701053754 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK
Material: 701053752 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4
Material: 701053486 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8805 ECC PACK
Material: 701053361 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 32200 ECC PACK
-
Material: 701053319 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC
Material:701052843 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 30300
Material:701052623 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD
Material: 701052461 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 6600 TUBING PACK
Material:701052324 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI
Material:701052287 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack
Material:701052285 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5502 ECC Pack
Material: 701051791 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack
Material: 701051515 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000
Material: 701051179 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15705
Material: 701051122 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 26300 CUSTOM PACK
Material: 701050975 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8
Material: 701050966 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8"
Material: 701050859 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 4901
Material: 701050839 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 22701
Material: 701050790 Terminated |
DWF | K080592 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.