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Atrium Medical Corporation

FDA Regulatory Profile

Summary

Total Recalls
150 (2 Class I)
510(k) Clearances
6
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0024-2025Class IIiCast Covered Stent, 6MMx16MMx120CM, Model Number 42616September 9, 2024
Z-2011-2024Class IIFLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1985-2024Class IIADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1987-2024Class IIADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-2007-2024Class IIFLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1957-2024Class IIADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftMay 3, 2024
Z-1954-2024Class IIADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftMay 3, 2024
Z-1986-2024Class IIADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-2015-2024Class IIFLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1960-2024Class IIADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftMay 3, 2024
Z-1970-2024Class IIADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1968-2024Class IIADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1996-2024Class IIADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1966-2024Class IIADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1980-2024Class IIADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1979-2024Class IIADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-2010-2024Class IIFLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-2012-2024Class IIFLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftMay 3, 2024
Z-2003-2024Class IIFLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graftMay 3, 2024
Z-1959-2024Class IIADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftMay 3, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K231972Advanta VXT Vascular Graft, Flixene Vascular GraftMarch 28, 2024
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal ChesSeptember 3, 2021
K151386C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicOctober 22, 2015
K151437ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugAugust 27, 2015
K130142FLIXENE IFG VASCULAR GRAFTMarch 15, 2013
K110110ATRIUM CENTRILFX MESHFebruary 15, 2011