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) |
|---|---|---|---|
| Dec 28, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:
Terminated |
DWF | K012538 K113845 +2 |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Soft Flow Ang W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of u Terminated |
DWF | K934127 |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Soft Flow Ang Wire W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | K934127 |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 18 Fr 6mm Sft Flow Ang Wire W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | K934127 |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 18 Fr 6mm Sft Flow Angled Wire
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours o Terminated |
DWF | K934127 |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Sft Flow Straight
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of u Terminated |
DWF | K934127 |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Sft Flow Straight Wir
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | None listed |
| Dec 3, 2012 | Terumo Cardiovascular Systems Corporation 24 Fr 8mm Sft Flow Str Wire W/L
The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours Terminated |
DWF | K934127 |
| Jul 9, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081.
Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart dur Terminated |
DWF | K831759 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT-DR BARTLES
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to t Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT-DR VANTRIGHT
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT-DR VANTRIGHT
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT- DR HENDRICKSO
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT- DR OWEN
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT-DR GERHARDT
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation CUSTOM CPB CATHETER KIT-DR.
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to t Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation X-COATED H/L PK W/FX15RW40
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to th Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation X-COATED FX25RW H/L PACK
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation MAYO MN XCOATED 3/8X1/2 AV
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to th Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation X-COATED SMALL PATIENT PACK
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to t Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation X-COATED SMALL PATIENT PACK
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to t Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation X-COATED TRANSPLANT PACK
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation XC HEART/LUNG PACK W/SX25RX
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to t Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation INDIANA/OHIO HEART
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation FX PACK
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent th Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG
Product Usage:
The Sarns Cardioplegia Cannula and Cardiopleg Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG
Product Usage:
The Sarns Cardioplegia Cannula and Cardiople Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Terminated |
DWF | K873212 |
| Jun 27, 2012 | Terumo Cardiovascular Systems Corporation Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG
Product Usage:
The Sarns Cardioplegia Cannula and Cardioplegia/Vent Ca Terminated |
DWF | K873212 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation CPB CATHETER KIT- DR.VAN TRIGHT.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | K770429 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation CUSTOM CPB CATHETER KIT-DR.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | K770429 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SPECIALTYCARE - HUDGENS.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | K770429 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation 24FR FLEX ART CANN NON STERILE.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terminated |
DWF | K770429 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta Terminated |
DWF | K771499 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta du Terminated |
DWF | K771499 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta Terminated |
DWF | K771499 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta Terminated |
DWF | K771499 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion Terminated |
DWF | K083301 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during c Terminated |
DWF | K770429 |
| Jun 20, 2012 | Terumo Cardiovascular Systems Corporation SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during Terminated |
DWF | K770429 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Glendale Memorial Fx Pack
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce t Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Glendale Memorial XCoated Pack
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to red Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Glendale Memorial XCoated Pack
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to red 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 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated 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 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long, with Xcoating" surface coating
Product Usage:
The 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 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicat Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated for use In p Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfu Terminated |
DWF | K083301 K934127 |
| Mar 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) lonq
Product Usage:
The Sarns-Aortic Cannula is indicated for use In perfusion of the asc 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 7.0mm (21 Fr) OD with 3/8" connector, 14" (36cm) long
Product Usage:
The Sarns-Aortic Cannula is indicated Terminated |
DWF | K083301 K934127 |
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