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) |
|---|---|---|---|
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | K881330 |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | K881330 |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | K881330 |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | K881330 |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | K881330 |
| Jul 22, 2010 | Sorin Group USA, Inc. Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5. Terminated |
DWF | K082344 |
| Mar 12, 2010 | Sorin Group USA, Inc. , REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours. Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of up to Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | K881330 |
| Mar 12, 2010 | Sorin Group USA, Inc. Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for p Terminated |
DWF | K881330 |
| Aug 31, 2009 | Maquet Cardiovascular Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch conne Terminated |
DWF | None listed |
| Aug 26, 2009 | Bard Peripheral Vas MR Coaxial 10g x 118mm (VC10118MR). Terminated |
DWF | K082681 |
| Aug 26, 2009 | Bard Peripheral Vas MR Coaxial 10g x 140mm (VC10140MR). Terminated |
DWF | K082681 |
| Aug 26, 2009 | Bard Peripheral Vas Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P). Terminated |
DWF | K082681 |
| Aug 26, 2009 | Bard Peripheral Vas Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P). Terminated |
DWF | K082681 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577.
The TenderFlow (TM) Pediatric Arterial Cannula is indicate Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573.
The TenderFlow (TM) Pediatric Arterial Cannula is indicate Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570.
The TenderFlow (TM) Pediatric Arterial Cannula is indicat Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568.
The TenderFlow (TM) Pediatric Arterial Cannula is indicat Terminated |
DWF | K063618 |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | K063618 |
| Jan 26, 2009 | Medtronic Cardiovascular Revascularization & Surgical Therap DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers. Terminated |
DWF | K850385 |
| Sep 26, 2008 | Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O, 33/43 Fr. x 39 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
Intended for cannula drainage of the superior and infer Terminated |
DWF | K831769 |
| Sep 26, 2008 | Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
Intended for cannula drainage of the superior and inferior vena cava during Terminated |
DWF | K831769 |
| Sep 26, 2008 | Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614
Intended for cannula drainage of the superior and inferior vena cava during ex Terminated |
DWF | K831769 |
| Sep 11, 2008 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing. Terminated |
DWF | K033464 K891576 |
| Sep 11, 2008 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing. Terminated |
DWF | K033464 K891576 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available OUS. Catalog number: M470450E Terminated |
DWF | None listed |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029. Terminated |
DWF | K924642 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022. Terminated |
DWF | K840002 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound PVC bodies with angled, beveled tips. Catalog Number: CB78722 Terminated |
DWF | K033416 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010. Terminated |
DWF | K840001 |
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