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) |
|---|---|---|---|
| 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 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 12 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 122mm - delivery system 14 FR; Catalog no. TFLE- 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 105mm - delivery system 14 FR; Catalog no. TFLE- 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 10 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 10 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 10 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 10 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 10 mm - usable length 122mm - delivery system 14 FR; Catalog no. TFLE- 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 10 mm - usable length 105mm - delivery system 14 FR;Catalog no. TFLE-1 Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body l Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Reorder # PLVTW-14.0-38-30-BNS.
Silhouette Transitionless Peel-Away Introducer Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Endovascular Graft Iliac Leg Extensions - diameter 14 mm - length 55 mm -introducer sheath size 14 FR; Reorder no. ESLE-14-55-TAG. Terminated |
MIH | None listed |
| Jul 27, 2004 | Cook, Inc. Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80. Terminated |
MIH | None listed |
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