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)
Top companies in DWE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2019 | LivaNova 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 |
DWE | K981613 |
| Dec 20, 2017 | Maquet 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 |
DWE | K053025 |
| Dec 19, 2017 | LivaNova 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 |
DWE | K981613 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 50903 Custom ECC Pack-Pedriatric
, Custom Tubing Kit, Catalog No. 709000078 Terminated |
DWE | K080592 |
| Oct 19, 2017 | Datascope Corporation NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 Terminated |
DWE | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02 Terminated |
DWE | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02 Terminated |
DWE | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01 Terminated |
DWE | K080592 |
| Oct 19, 2017 | Datascope Corporation BEQ-TOP 5210 ECC Set -
Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 Terminated |
DWE | K080592 |
| Jul 27, 2017 | Datascope 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 |
DWE | K080592 |
| Jul 27, 2017 | Datascope 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 |
DWE | K080592 |
| Jul 27, 2017 | Datascope 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 |
DWE | K080592 |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin 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 |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA Terminated |
DWE | K981613 |
| Mar 23, 2017 | Datascope 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 |
DWE | K080592 |
| May 20, 2016 | Angiodynamics 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 |
DWE | K142607 |
| May 20, 2016 | Angiodynamics 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 |
DWE | K092486 |
| May 9, 2016 | Datascope 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 |
DWE | None listed |
| Mar 11, 2016 | Datascope Corporation Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992 Terminated |
DWE | K080592 |
| Mar 11, 2016 | Datascope Corporation Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490 Terminated |
DWE | K080592 |
| Mar 11, 2016 | Datascope Corporation Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588 Terminated |
DWE | K080592 |
| Sep 4, 2015 | Medtronic Perfusion Systems MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11,
TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3,
TL7M46R7, TL2Q68R Terminated |
DWE | K012538 K122811 +2 |
| Feb 20, 2014 | Medtronic 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 |
DWE | K800178 |
| Aug 27, 2013 | Medtronic 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 |
DWE | K800178 |
| Jan 18, 2012 | Medtronic 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 |
DWE | K800178 |
| Mar 16, 2011 | Maquet 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 |
DWE | K080592 |
| Oct 6, 2010 | Maquet 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 |
DWE | K080592 |
| Sep 12, 2010 | Maquet Inc. Maquet HLM Tubing Pack; Bioline Coating Terminated |
DWE | K053025 |
| Jun 23, 2009 | Medtronic Cardiovascular Revascularization & Surgical Therap Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits Terminated |
DWE | K800178 |
| Sep 25, 2007 | Medtronic 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 |
DWE | K800178 K891687 |
| Mar 8, 2007 | Medtronic 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 |
DWE | K800178 K891687 |
| Jan 25, 2007 | Medtronic 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 |
DWE | K800178 |
| Jul 12, 2006 | International Biophysics Corp IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX. Terminated |
DWE | K841959 |
| May 10, 2005 | Medtronic 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 |
DWE | K800178 K896978 |
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