ClearanceBrief
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)
Get daily alerts for DWFSample briefCSV

Top companies in DWF

DateFirm and productCodeLinked 510(k)
Oct 31, 2014Terumo 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
DWFK922992
Jul 23, 2014Terumo 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
DWFK790246
K905224
Jul 23, 2014Terumo 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
DWFK934127
Jul 23, 2014Terumo 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
DWFK080034
Jul 23, 2014Terumo 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
DWFK062597
K090878
Jul 23, 2014Terumo 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
DWFK920902
Jul 23, 2014Terumo 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
DWFK875048
Jul 23, 2014Terumo 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
DWFK770431
K920902
Jul 23, 2014Terumo 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
DWFK934127
Jul 23, 2014Terumo 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
DWFK834134
Jul 23, 2014Terumo 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
DWFK083301
K905224
Jul 23, 2014Terumo 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
DWFK083301
K920902
Jul 23, 2014Terumo 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
DWFK771499
Jul 23, 2014Terumo 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
DWFK874896
Apr 16, 2014Edwards 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
DWFK123298
Apr 16, 2014Edwards 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
DWFK123298
Mar 19, 2014Terumo 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
DWFK920902
Mar 19, 2014Terumo 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
DWFK920902
Mar 19, 2014Terumo 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
DWFK920902
Mar 19, 2014Terumo 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
DWFK920902
Mar 19, 2014Terumo 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
DWFK920902
Mar 19, 2014Terumo 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
DWFK920902
Mar 19, 2014Terumo 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
DWFK920902
Feb 20, 2014Medtronic 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
DWFK033416
Feb 20, 2014Medtronic 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
DWFK010737
Feb 20, 2014Medtronic 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
DWFK000776
Feb 20, 2014Medtronic 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
DWFK013013
Feb 20, 2014Medtronic 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
DWFK043179
Nov 8, 2013Terumo 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
DWFK934127
Nov 8, 2013Terumo 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
DWFK934127
Nov 8, 2013Terumo 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
DWFK934127
Nov 8, 2013Terumo 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
DWFK934127
Nov 1, 2013Edwards 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
DWFK123298
Nov 1, 2013Edwards 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
DWFK123370
Oct 31, 2013Edwards 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
DWFK022071
K102420
Aug 27, 2013Medtronic 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
DWFK012538
Aug 20, 2013Sorin Group USA, Inc.
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Terminated
DWFK881330
Aug 14, 2013Edwards 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
DWFK990396
Aug 14, 2013Edwards 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
DWFK971291
Jul 17, 2013Edwards 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
DWFK831759
May 14, 2013Edwards 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
DWFK120780
Apr 14, 2013Edwards 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
DWFK123298
Mar 5, 2013Medtronic 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
DWFK120988
K842375
Feb 20, 2013Maquet Cardiovascular Us Sales, Llc
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Terminated
DWFK002857
Jan 11, 2013Terumo 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;amp;quot; High Flow Aortic Arch Ca
Terminated
DWFK083301
K770429 +1
Jan 11, 2013Terumo 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;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;
Terminated
DWFK083301
K770429 +1
Jan 11, 2013Terumo 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;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp
Terminated
DWFK083301
K770429 +1
Jan 11, 2013Terumo 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;amp;quot; High Flow Aortic Arch Cannula and Sarns&a
Terminated
DWFK083301
K770429 +1
Jan 11, 2013Terumo 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;amp;quot; High Flow Aortic Arch Cannula and Sarn
Terminated
DWFK083301
K770429 +1
Jan 11, 2013Terumo 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;amp;quot; High Flow Aortic Arch Cannula and Sa
Terminated
DWFK083301
K770429 +1

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.