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) |
|---|---|---|---|
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascular Cardiopulmonary Bypass. Catalog Number: CB68122 Terminated |
DWF | K033264 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532 Terminated |
DWF | K842375 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp 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. Terminated |
DWF | K063618 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm and rigid stylet, 12.5'(31.8cm), sterile, REF CODE: RSR-M014S-L. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, rigid insertion stylet, sterile, REF CODE: RSR-L014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm self-inflating textured balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-T Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, handle stylet, sterile, REF CODE: RSH-T014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, handle stylet, sterile, REF CODE: RSH-L014S. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon, 15Fr (5.0mm), guidewire stylet, 12.5'(31.8cm), sterile, REF CODE: RSG-T014S-L. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, 12.5' (31.8cm), sterile, REF CODE: RSG-M014S-L. Terminated |
DWF | K964393 |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S. Terminated |
DWF | K964393 |
| Feb 27, 2007 | Terumo Cardiovascular Systems Corp Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351. Terminated |
DWF | K930620 |
| Feb 27, 2007 | Terumo Cardiovascular Systems Corp Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 10 FR, 17.5 cm (7'') long; Catalog no. L7350. Terminated |
DWF | K930620 |
| Jun 9, 2006 | Ethicon, Inc. Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244. Terminated |
DWF | K990772 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. , Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 23 cm, Edwards Lifesciences Terminated |
DWF | K831769 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm, Edwards Lifesciences Terminated |
DWF | K831769 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm
Edwards Lifesciences Terminated |
DWF | K831769 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm., Edwards Lifesciences Terminated |
DWF | K831769 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm
Edwards Lifesciences Terminated |
DWF | K831769 |
| Nov 26, 2005 | Terumo Cardiovascular Systems Corp Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only. Terminated |
DWF | K771499 |
| Nov 23, 2005 | Terumo Cardiovascular Systems Corp Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080. Terminated |
DWF | K934127 |
| Aug 3, 2005 | Maquet Inc Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter). Terminated |
DWF | None listed |
| Dec 15, 2004 | Edwards Lifesciences Research Medical Inc EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. Terminated |
DWF | K020693 |
| Sep 29, 2004 | Medtronic Inc Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036. Terminated |
DWF | K845045 K891687 |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, ribbed balloon; catalog number 7273. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet, ribbed balloon; catalog number 7272. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, smooth balloon; catalog number 7271. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet, smooth balloon; catalog number 7270. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5587. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed balloon, standard length, 12'' (30.5 cm) long; catalog number 5586. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, steerable stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5585. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, malleable stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5584. Terminated |
DWF | None listed |
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