Panels › Cardiovascular › Product code DTN · Class 2
Reservoir, Blood, Cardiopulmonary Bypass
Regulation 870.4400
1510(k)s in 12 months (169 all time)
0recalls in 12 months (47 all time)
46recalls that name a 510(k)
Top companies in DTN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2023 | Maquet Medical Systems USA Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA 701070445 Open, Classified |
DTN | K102919 |
| Apr 27, 2021 | Circulatory Technology Inc. The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 Open, Classified |
DTN | K981284 |
| Mar 17, 2021 | Medtronic Perfusion Systems Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood during Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to colle Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood during ext Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device design Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir Terminated |
DTN | K183511 |
| Mar 17, 2021 | Medtronic Perfusion Systems Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CV Terminated |
DTN | K183511 |
| Mar 1, 2018 | Circulatory Technology Inc **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers) Terminated |
DTN | K981284 |
| Mar 1, 2018 | Circulatory Technology Inc Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers) Terminated |
DTN | K981284 |
| Jan 16, 2018 | Medtronic Perfusion Systems Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T
The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device desig Terminated |
DTN | K021287 |
| Jan 16, 2018 | Medtronic Perfusion Systems Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540
The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood Terminated |
DTN | K936003 |
| Oct 19, 2017 | Datascope Corporation BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-T 25502 1/4 Better Bladder
, Custom Tubing Kit, Catalog No. 709000434 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 22701, Catalog No. 701050790 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 22702 ECC W/HMOD
30000, Catalog No. 701051179 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513 Terminated |
DTN | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 Terminated |
DTN | K080592 |
| Oct 7, 2016 | Circulatory Technology Inc The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE,
Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. Terminated |
DTN | K981284 |
| Jul 1, 2016 | Circulatory Technology Inc The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72
A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal Terminated |
DTN | K981284 |
| Mar 3, 2016 | Circulatory Technology Inc Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 Terminated |
DTN | K981284 |
| Aug 4, 2011 | Terumo Cardiovascular Corporation CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Terminated |
DTN | None listed |
| Apr 13, 2010 | Circulatory Technology Inc The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624- Terminated |
DTN | K981284 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas exchange device for Cardiopulmonary Bypass. Catalog Number: 71166 Terminated |
DTN | K031700 |
| Jan 26, 2008 | Medtronic Perfusion Systems Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804 Terminated |
DTN | K930154 |
| Jul 20, 2004 | Cobe Cardiovascular, Inc Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt Terminated |
DTN | K934847 |
| Jul 2, 2003 | Cobe Cardiovascular, Inc Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Terminated |
DTN | K934847 |
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