ClearanceBrief
Panels › Cardiovascular › Product code DWE · Class 2

Tubing, Pump, Cardiopulmonary Bypass

Regulation 870.4390

0510(k)s in 12 months (21 all time)
0recalls in 12 months (48 all time)
47recalls that name a 510(k)
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Top companies in DWE

DateFirm and productCodeLinked 510(k)
Jul 3, 2019LivaNova USA Inc.
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs includ
Terminated
DWEK981613
Dec 20, 2017Maquet
Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
Terminated
DWEK053025
Dec 19, 2017LivaNova USA
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Terminated
DWEK981613
Oct 19, 2017Datascope Corporation
BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
Terminated
DWEK080592
Oct 19, 2017Datascope Corporation
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
Terminated
DWEK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
Terminated
DWEK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
Terminated
DWEK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Terminated
DWEK080592
Oct 19, 2017Datascope Corporation
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
Terminated
DWEK080592
Jul 27, 2017Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device
Terminated
DWEK080592
Jul 27, 2017Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic devi
Terminated
DWEK080592
Jul 27, 2017Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for
Terminated
DWEK080592
Jun 29, 2017Sorin Group USA, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Jun 29, 2017Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
Terminated
DWEK981613
Mar 23, 2017Datascope Corporation
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bu
Terminated
DWEK080592
May 20, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the Angio
Terminated
DWEK142607
May 20, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Terminated
DWEK092486
May 9, 2016Datascope Corporation
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets th
Terminated
DWENone listed
Mar 11, 2016Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
Terminated
DWEK080592
Mar 11, 2016Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Terminated
DWEK080592
Mar 11, 2016Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Terminated
DWEK080592
Sep 4, 2015Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R
Terminated
DWEK012538
K122811 +2
Feb 20, 2014Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide
Terminated
DWEK800178
Aug 27, 2013Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This pr
Terminated
DWEK800178
Jan 18, 2012Medtronic Inc. Cardiac Rhythm Disease Management
Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601
Terminated
DWEK800178
Mar 16, 2011Maquet Cardiovascular, LLC
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 c
Terminated
DWEK080592
Oct 6, 2010Maquet Inc.
MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
Terminated
DWEK080592
Sep 12, 2010Maquet Inc.
Maquet HLM Tubing Pack; Bioline Coating
Terminated
DWEK053025
Jun 23, 2009Medtronic Cardiovascular Revascularization & Surgical Therap
Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
Terminated
DWEK800178
Sep 25, 2007Medtronic Perfusion Systems
Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and
Terminated
DWEK800178
K891687
Mar 8, 2007Medtronic Perfusion Systems
Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuu
Terminated
DWEK800178
K891687
Jan 25, 2007Medtronic Perfusion Systems
Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any c
Terminated
DWEK800178
Jul 12, 2006International Biophysics Corp
IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
Terminated
DWEK841959
May 10, 2005Medtronic Perfusion Systems
Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept
Terminated
DWEK800178
K896978

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