Panels › Cardiovascular › Product code DSY · Class 2

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Regulation 870.3450

1510(k)s in 12 months (188 all time)

2recalls in 12 months (87 all time)

86recalls that name a 510(k)

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Top companies in DSY

Company	510(k)s	Recalls
Atrium Medical Corp.	18	66
W. L. Gore & Associates, Inc.	24	3
Vascutek, Ltd.	22	3
Intervascular	17	1
Meadox Medicals, Div. Boston Scientific Corp.	15	0
Impra, Inc.	10	0
Maquet Cardiovascular, LLC	3	7
C.R. Bard, Inc.	7	0
Peca Labs	5	0
Shiley, Inc.	5	0

Date	Firm and product	Code	Linked 510(k)
Sep 23, 2026	INTERVASCULAR, SAS Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034; Open, Classified	DSY	K103347
Mar 4, 2026	Vascutek, Ltd. Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, Open, Classified	DSY	K241070 K241550
Oct 2, 2025	W L Gore & Associates, Inc. GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, Open, Classified	DSY	K233551
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K060124 K071923
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified	DSY	K992960
Jun 4, 2024	Atrium Medical Corporation ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified	DSY	K992960

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