Panels › Cardiovascular › Product code DWF · Class 2
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation 870.4210
8510(k)s in 12 months (403 all time)
20recalls in 12 months (563 all time)
544recalls that name a 510(k)
Top companies in DWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular | 0 | 184 |
| Terumo Cardiovascular Systems Corp. | 10 | 143 |
| Medtronic Perfusion Systems | 12 | 77 |
| Sorin Group USA, Inc. | 0 | 47 |
| Edwards Lifesciences | 19 | 21 |
| Medtronic, Inc. | 31 | 1 |
| Dlp, Inc. | 22 | 0 |
| 3M Health Care, Sarns | 21 | 0 |
| Shiley, Inc. | 21 | 0 |
| Edwards Lifesciences Research Medical | 4 | 13 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24500 ADULT ECC
Material: 701050253 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB
Material: 701050228 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 21502# Med City Childr
Material: 701050060 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack
Material: 701049994 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 3700 Tubing Pack
Material: 701049510 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T-22800
Material: 701049506 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK
Material: 701049346 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack
Material: 701048690 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient
Material: 701048539 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32
Material: 701047962 Terminated |
DWF | K080592 |
| May 31, 2019 | Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 15800 TUBING PACK
Material: 3000065087 Terminated |
DWF | K080592 |
| Nov 9, 2018 | LivaNova USA Perfusion Pack, Rx only, Sterile EO Terminated |
DWF | K881330 |
| Nov 7, 2018 | OriGen Biomedical, Inc. REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473
Product Usage:
The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainag Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO
Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion o Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO
Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusi Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO
Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO
Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion o Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO
Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of Terminated |
DWF | K113869 |
| Aug 21, 2018 | OriGen Biomedical, Inc. Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Indications: The OriGen Reinforced Dual Lumen Cannula is indicated Terminated |
DWF | K113869 |
| Jul 18, 2018 | Surge Medical Sales, LLC (DBA Surge Cardiovascular) Retrograde Cardioplegia Cannula, Model Number RMG-0015S
The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of Terminated |
DWF | K964199 |
| May 14, 2018 | Maquet Cardiopulmonary Ag Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass Terminated |
DWF | K012774 |
| May 14, 2018 | Maquet Cardiopulmonary Ag Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass Terminated |
DWF | K012774 |
| May 14, 2018 | Maquet Cardiopulmonary Ag Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass Terminated |
DWF | K012774 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. Terminated |
DWF | K140208 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. Terminated |
DWF | K140208 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized. Terminated |
DWF | K120072 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized. Terminated |
DWF | K120072 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized. Terminated |
DWF | K120072 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. Terminated |
DWF | K123370 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. Terminated |
DWF | K123370 |
| Jan 30, 2018 | Medtronic Perfusion Systems Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures. Terminated |
DWF | K171308 |
| Oct 20, 2017 | OriGen Biomedical, Inc. The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat Terminated |
DWF | K113869 |
| Sep 28, 2017 | Sorin Group USA, Inc. FlexFlow Venous Cannula Model/Catalog Number 200-200
The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective Terminated |
DWF | K052081 |
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Pressure Monitoring Extension Line Adapters
Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery. Terminated |
DWF | K831591 |
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Cardioplegia Adapter with Pressure Port
Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with t Terminated |
DWF | K831591 |
| Jun 9, 2017 | Sorin Group USA, Inc. Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile
Product Usage:
The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary by Terminated |
DWF | K943934 |
| Sep 8, 2016 | Sorin Group USA, Inc. Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl fe Terminated |
DWF | K030231 K972503 |
| Sep 8, 2016 | Sorin Group USA, Inc. Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypas Terminated |
DWF | K943934 |
| Jul 8, 2016 | Sorin Group USA, Inc. AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)
Aortic Arch Cannulae are designed to be used in the extracorporeal circuit durin Terminated |
DWF | K943934 |
| Feb 26, 2016 | Medtronic Perfusion Systems Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO.
Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Terminated |
DWF | K012538 K891687 +1 |
| Feb 16, 2016 | Sorin Group USA, Inc. Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Car Terminated |
DWF | K943934 |
| Jan 19, 2016 | Sorin Group USA, Inc. CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack.
Product Usage:
Heart/Lung Perfusion Pack is either a customized tubing pack built Terminated |
DWF | K881330 |
| Dec 9, 2015 | Edwards Lifesciences, LLC Thin-Flex Venous Cannula, Model Number:TF292902A Terminated |
DWF | K120072 |
| Oct 28, 2015 | Medtronic Perfusion Systems Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide.
The Tubing Pack design and components are specified by the user, they are packaged with consi Terminated |
DWF | K012538 |
| Aug 19, 2015 | Medtronic Perfusion Systems Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. Terminated |
DWF | K031037 |
| Jun 26, 2015 | Medtronic Perfusion Systems Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide.
The cannula and dilator com Terminated |
DWF | K875353 |
| Apr 23, 2015 | OriGen Biomedical, Inc. OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical.
OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a sin Terminated |
DWF | K113869 |
| Apr 2, 2015 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEM Terminated |
DWF | K140208 |
| Nov 14, 2014 | Edwards Lifesciences, LLC Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012
Atrial Vent Catheters are intended for venting the left Terminated |
DWF | K113411 |
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