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Panels › Cardiovascular › Product code DYF · Class 2

Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Regulation 870.3450

0510(k)s in 12 months (21 all time)

0recalls in 12 months (17 all time)

17recalls that name a 510(k)

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Top companies in DYF

Company	510(k)s	Recalls
Atrium Medical Corp.	4	17
W. L. Gore & Associates, Inc.	8	0
Impra, Inc.	6	0
Baxter Healthcare Corp	1	0
Meadox Medicals, Div. Boston Scientific Corp.	1	0
Possis Medical, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified	DYF	K992958
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified	DYF	K992958
Sep 30, 2013	Atrium Medical Corporation Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated	DYF	K992958
Sep 30, 2013	Atrium Medical Corporation Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated	DYF	K000504
Sep 30, 2013	Atrium Medical Corporation Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated	DYF	K992441

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