510(k) K080592 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
HLM TUBING SET WITH BIOLINE COATING
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Sep 11, 2008 |
| Received | Mar 3, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15800 TUBING PACK
Material: 3000065087 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32
Material: 701047962 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient
Material: 701048539 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack
Material: 701048690 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK
Material: 701049346 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T-22800
Material: 701049506 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 3700 Tubing Pack
Material: 701049510 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack
Material: 701049994 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21502# Med City Childr
Material: 701050060 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB
Material: 701050228 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24500 ADULT ECC
Material: 701050253 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 22701
Material: 701050790 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 4901
Material: 701050839 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8"
Material: 701050859 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8
Material: 701050966 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 26300 CUSTOM PACK
Material: 701050975 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15705
Material: 701051122 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000
Material: 701051179 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack
Material: 701051515 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5502 ECC Pack
Material: 701051791 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack
Material:701052285 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI
Material:701052287 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 6600 TUBING PACK
Material:701052324 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD
Material: 701052461 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 30300
Material:701052623 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC
Material:701052843 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 32200 ECC PACK
-
Material: 701053319 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8805 ECC PACK
Material: 701053361 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4
Material: 701053486 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK
Material: 701053752 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK
Material: 701053754 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK
Material: 701053845 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25001 MONTEFIORE
Material: 701053906 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK
Material: 701054150 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24202 ADULT ECC
Material:701054295 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC
Material:701054438 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP
Material:701054776 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 13901 RAPID RESPONSE
Material:701054874 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 22706 SAMPLE MANIFOLD
Material:701054912 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32
Material:701055142 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK
Material: 701055372 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC
Material: 701055388 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID
Material: 701055601 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY
Material: Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID
Material: 701055862 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID
Material: 701055866 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 8028 PRESSURE PIGTAIL 4"
Material: 701055993 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 8029 PRESSURE PIGTAIL 6"
Material: 701055995 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK
Material: 701056041 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 38900 ECC PACK
Material: 701056368 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 26402 ECC PACK
Material: 701062310 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 39700 ECC PACK
Material:701062473 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT
Material:701062613 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 40700 HUNTINGTON
Material:701062899 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK
Material:701063071 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC
Material: 701063149 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM
Material: 701063255 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21506 ECC PACK
Material:701064505 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 5211 LARGE ECC SET
Material:701064560 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY
Material: 701064590 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT
Material: 701064701 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24105 ECC PACK
Material:701064757 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK
Material:701064804 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC
Material: 701064825 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P
Material: 701064831 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK
Material: 701064834 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC
Material: 701064867 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8069 Pediatric Pack
Material: 701064965 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID
Material: 701064992 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack
Material: 701065190 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 41301 BUMC ECC PACK
Material: 701065209 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4"
Material: 701065504 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO
Material: 701065510 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI
Material: 701065512 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack
Material: 701065620 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 36504 ADULT ECC PACK
Material: 701065765 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK
Material: 701065770 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 46500 PRIME PACK
Material:701065823 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION
Material:701066097 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 41302 PRIMING LINES BUMC
Material:701066291 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P
Material:701066366 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA
Material:701066551 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED
Material:701066583 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy
Material:701066664 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE
Material: 701066883 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK
Material: 701067203 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK
Material: 701067280 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC
Material: 701067350 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU
Material: 701067372 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE
Material: 701067577 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-TOP 35503 SGD PACK
Material: 701067668 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK
Material: 701067837 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 3501 LVAD/ 3/8"
Material: 701068008 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 3502 LVAD 1/4"
Material: 701068168 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK
Material: 701068395 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 35503 SGD Pack
Material: 701068797 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack
Material: 701068798 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery
Material:709000004 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack
Material: 709000006 Terminated |
DWF | None listed |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4"
Material: 709000011 Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.