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) |
|---|---|---|---|
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 7.0mm (21 Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 12" (31cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for us Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8" connector, 12" (31 cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8" connector, 12" (31cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusi Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8" connector,12" (31cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for u Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating
Product Usage: CTS Usage:
The Sarn Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating
Product Usage: CTS Usage:
The Sarn Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated f Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm)
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is i Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with 0580178 luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 8.75" (22cm) long
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating" surface coating.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicat Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the as Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating surface coating.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicat Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the as Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 12" (31 em) long.
Product Usage: CTS Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the as Terminated |
DWF | K083301 K934127 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic.
Model # 's
CB66112, CB66114, CB66116, CB66118, CB66120, C Terminated |
DWF | K022272 K842375 +1 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, DLP, DLP Malleable Single Stage Venous CannulaeRx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic.
Model # 91037.
These cannulae are intended for collection of venous blood from the Terminated |
DWF | K854487 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae.
Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s
68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 6 Terminated |
DWF | K022272 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae.
Rx Only, Sterile EO, Nonpyrogenic. Model #'s
67512, 67514, 67516, 67518, 67520, 67522, 67524, 67526, 67528, 67530, 67532, 67534, 67636. Terminated |
DWF | K842375 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic DLP, DLP Single Stage Venous Cannulae.
Rx Only, Sterile EO, Nonpyrogenic. Model #'s
66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240 Terminated |
DWF | K845045 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.
Rx Only, Sterile EO, Nonpyrogenic. Model number #'s :
67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, Terminated |
DWF | K842375 |
| Jul 11, 2011 | Edwards Lifesciences, LLC Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems.
Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for Terminated |
DWF | K023880 K981909 |
| Jul 11, 2011 | Edwards Lifesciences, LLC Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA.
Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for Terminated |
DWF | K964248 K981909 |
| Jun 14, 2011 | Terumo Cardiovascular Systems Corporation 804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, per Terminated |
DWF | K822210 |
| Jun 14, 2011 | Terumo Cardiovascular Systems Corporation 804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, per Terminated |
DWF | K822210 |
| Jun 14, 2011 | Terumo Cardiovascular Systems Corporation 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, per Terminated |
DWF | K822210 |
| May 13, 2011 | Edwards Lifesciences Llc Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
The cannula perfuses blood to the ascending aorta du Terminated |
DWF | K033463 |
| Jan 28, 2011 | Edwards Lifesciences Llc Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
The Steerable Coronary Sinus Catheter is a three-lumen, 9 Terminated |
DWF | K023880 |
| Jan 28, 2011 | Edwards Lifesciences Llc EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614.
The EndoPlege coronary sinus catheter is a three-lumen, 9 F Terminated |
DWF | K964248 |
| Jan 10, 2011 | Cardiac Assist, Inc TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly
The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for Terminated |
DWF | K052570 |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, 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 084504500, 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 084504300, 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 084503500, 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 084503400, 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 084503000, 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 084502100, 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 084502000, 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 084501200, 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 084501001, 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 084500900, 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 084500800, 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 084500700, 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 084500600, 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 084500501, 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 084500500, 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 084500300, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | K881330 |
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