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) |
|---|---|---|---|
| Feb 3, 2005 | Cook, Inc. Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-111. 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= 26mm, B=141mm, C=111mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-111. 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= 24mm, B=141mm, C=111mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-111. 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= 22mm, B=141mm, C=111mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-111. 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= 32mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-96. 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=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-96. 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=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-96. 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=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96. 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=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-96. 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=126mm, C=96mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-96. 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=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-82. 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=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82. 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=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-82. 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=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82. 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=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-82. 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=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-82. Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-C-KTI. Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-0-KTI. Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI-BNS. Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 65 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI. Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 8 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-8- Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 8 mm - usable length 105mm - delivery system 14 FR; Catalog no. TFLE-8 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 22 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 22 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 22 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 22 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-2 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 71mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-14 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14 mm - usable length 71mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-14 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 71mm - delivery system 14 FR; Catalog no. TFLE-1 Terminated |
MIH | None listed |
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