Product code MIH ยท Class 3
System, Endovascular Graft, Aortic Aneurysm Treatment
0510(k)s in 12 months (0 all time)
2recalls in 12 months (176 all time)
0recalls that name a 510(k)
Top companies in MIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Inc. | 0 | 121 |
| Endologix | 0 | 23 |
| Medtronic Vascular, Inc. | 0 | 11 |
| W L Gore & Associates, Inc. | 0 | 7 |
| Bolton Medical Inc. | 0 | 5 |
| Trivascular, Inc | 0 | 3 |
| Cook Medical Incorporated | 0 | 2 |
| W L Gore & Assoc, Inc. | 0 | 2 |
| Bard Peripheral Vascular Inc | 0 | 1 |
| Medtronic CardioVascular | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-22-73-ZT, REF G48474, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-14-56-ZT, REF G48455, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, 22 Fr ID/ 8.5 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428, 20 Fr ID/ 7.7 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, 20 Fr ID/ 7.7 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422, 20 Fr ID/ 7.7 mm OD Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-28-96-ZT, REF G48418, 20 Fr ID/ 7.7 mm OD, Sterile Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF G48415, 18 Fr ID/ 7.1 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical, Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-96-ZT, REF G48413, 18 Fr ID/ 7.1 mm OD, Sterile. Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-96-ZT, REF G48408, 18 Fr ID/ 7.1 mm OD, Sterile Terminated |
MIH | None listed |
| Sep 6, 2011 | Cook, Inc. Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile Terminated |
MIH | None listed |
| Apr 8, 2008 | Medtronic CardioVascular Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System;
Model Numbers Affected: All AAAdvantage models including:
AEXC202040, IEXC121255, ILXC1212115, I Terminated |
MIH | None listed |
| Dec 27, 2006 | Endologix Inc Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL Terminated |
MIH | None listed |
| Dec 27, 2006 | Endologix Inc Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL Terminated |
MIH | None listed |
| Jul 13, 2006 | W L Gore & Assoc, Inc. GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm Terminated |
MIH | None listed |
| Jul 13, 2006 | W L Gore & Assoc, Inc. GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A=32mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-140. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-140. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-140. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=170mm, C=140mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-140. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-125. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-125. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-125. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-125. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-125. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=155mm, C=125mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-125. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-111. Terminated |
MIH | None listed |
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-111. Terminated |
MIH | None listed |
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