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) |
|---|---|---|---|
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Cardioplegia Delivery Set-
Catalog Number:165720 and Catalog Number: 6375
Product Usage:
Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoi Terminated |
DWF | K922992 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation CPB Catheter Kit
Product Usage:
Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Terminated |
DWF | K790246 K905224 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the a Terminated |
DWF | K934127 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare.
Product Usage:
Venous Return Cannula is indicated for venous drainage during card Terminated |
DWF | K080034 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare,
Product Usage:
Venous Return Cannula is indicated for venous drainage dur Terminated |
DWF | K062597 K090878 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector
Product Usage:
Venous Return Cannula is indicated for venous drainage during cardiop Terminated |
DWF | K920902 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These Terminated |
DWF | K875048 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector
Product Usage:
The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass sur Terminated |
DWF | K770431 K920902 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating,
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmona Terminated |
DWF | K934127 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surg Terminated |
DWF | K834134 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating
Product Usage: The Venous Return Cannula is indicated for venous dra Terminated |
DWF | K083301 K905224 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating
Product Usage: The Venous Return Cannula is indicated for venous drainage durin Terminated |
DWF | K083301 K920902 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector
Product Usage:
The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Th Terminated |
DWF | K771499 |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer
Product Usage:
The Sarns Aortic Cannula is indicated for use in perfusion of the ascendin Terminated |
DWF | K874896 |
| Apr 16, 2014 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII0 Terminated |
DWF | K123298 |
| Apr 16, 2014 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS. Terminated |
DWF | K123298 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venou Terminated |
DWF | K920902 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venou Terminated |
DWF | K920902 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Re Terminated |
DWF | K920902 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are Terminated |
DWF | K920902 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are Terminated |
DWF | K920902 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Terminated |
DWF | K920902 |
| Mar 19, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long
The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula a Terminated |
DWF | K920902 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Select 3D Arterial Cannulae has clear flexible, th Terminated |
DWF | K033416 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using E Terminated |
DWF | K010737 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Cannula consists of a curved Terminated |
DWF | K000776 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Cannula consists of a curved Terminated |
DWF | K013013 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyroge Terminated |
DWF | K043179 |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long.
Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena c Terminated |
DWF | K934127 |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in per Terminated |
DWF | K934127 |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in per Terminated |
DWF | K934127 |
| Nov 8, 2013 | Terumo Cardiovascular Systems Corporation Sarns" Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in perfu Terminated |
DWF | K934127 |
| Nov 1, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only,
Product Usage:
Aortic perfusion cannulae are intended for perfusion of the ascend Terminated |
DWF | K123298 |
| Nov 1, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only,
Product Usage:
Edwards Lifesciences femoral access cannulae are intend Terminated |
DWF | K123370 |
| Oct 31, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
The E Terminated |
DWF | K022071 K102420 |
| Aug 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7.
Sterilized by E Terminated |
DWF | K012538 |
| Aug 20, 2013 | Sorin Group USA, Inc. Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. Terminated |
DWF | K881330 |
| Aug 14, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25
Anastaflo shunts are intended for use in preventing i Terminated |
DWF | K990396 |
| Aug 14, 2013 | Edwards Lifesciences, LLC Edwards EndoReturn Arterial Cannula, model ER21B and ER23B
Product Usage:
The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector h Terminated |
DWF | K971291 |
| Jul 17, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Suction Wand, models S099 and S0998B
Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical Terminated |
DWF | K831759 |
| May 14, 2013 | Edwards Lifesciences, LLC Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9.
Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate Terminated |
DWF | K120780 |
| Apr 14, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Duraflo coated Femoral Cannula.
Product Usage:
The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours Terminated |
DWF | K123298 |
| Mar 5, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures.
Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318 Terminated |
DWF | K120988 K842375 |
| Feb 20, 2013 | Maquet Cardiovascular Us Sales, Llc Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants. Terminated |
DWF | K002857 |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface
The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Ca Terminated |
DWF | K083301 K770429 +1 |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long
The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp; Terminated |
DWF | K083301 K770429 +1 |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long
The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp Terminated |
DWF | K083301 K770429 +1 |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long
The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&a Terminated |
DWF | K083301 K770429 +1 |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long
The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarn Terminated |
DWF | K083301 K770429 +1 |
| Jan 11, 2013 | Terumo Cardiovascular Systems Corporation Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long
The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sa Terminated |
DWF | K083301 K770429 +1 |
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