ClearanceBrief
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)
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Top companies in DTN

DateFirm and productCodeLinked 510(k)
May 26, 2023Maquet Medical Systems USA
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Open, Classified
DTNK102919
Apr 27, 2021Circulatory Technology Inc.
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Open, Classified
DTNK981284
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 17, 2021Medtronic 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
DTNK183511
Mar 1, 2018Circulatory 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
DTNK981284
Mar 1, 2018Circulatory Technology Inc
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Terminated
DTNK981284
Jan 16, 2018Medtronic 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
DTNK021287
Jan 16, 2018Medtronic 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
DTNK936003
Oct 19, 2017Datascope Corporation
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 22701, Catalog No. 701050790
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
Terminated
DTNK080592
Oct 19, 2017Datascope Corporation
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
Terminated
DTNK080592
Oct 7, 2016Circulatory 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
DTNK981284
Jul 1, 2016Circulatory 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
DTNK981284
Mar 3, 2016Circulatory Technology Inc
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Terminated
DTNK981284
Aug 4, 2011Terumo 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
DTNNone listed
Apr 13, 2010Circulatory 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
DTNK981284
Jul 24, 2008Medtronic 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
DTNK031700
Jan 26, 2008Medtronic Perfusion Systems
Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804
Terminated
DTNK930154
Jul 20, 2004Cobe Cardiovascular, Inc
Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
Terminated
DTNK934847
Jul 2, 2003Cobe Cardiovascular, Inc
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
Terminated
DTNK934847

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