Product code PRL ยท Class 3
Iliac Covered Stent, Arterial
0510(k)s in 12 months (0 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in PRL
| Company | 510(k)s | Recalls |
|---|---|---|
| W L Gore & Associates, Inc. | 0 | 3 |
| Atrium Medical Corporation | 0 | 2 |
| Bard Peripheral Vascular Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2024 | Atrium Medical Corporation iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 Open, Classified |
PRL | None listed |
| Aug 30, 2024 | W L Gore & Associates, Inc. Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:
United States:
BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, B Open, Classified |
PRL | None listed |
| Aug 30, 2024 | W L Gore & Associates, Inc. Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:
United States:
BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A
BXB053901A BXB05390 Open, Classified |
PRL | None listed |
| Nov 11, 2023 | Atrium Medical Corporation Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter A Open, Classified |
PRL | None listed |
| Sep 7, 2021 | W L Gore & Associates, Inc. Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI: Open, Classified |
PRL | None listed |
| Dec 19, 2019 | Bard Peripheral Vascular Inc LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 at Terminated |
PRL | None listed |
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