Company ยท US
Atrium Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2024. Name variants (Inc, Corp, punctuation) are merged.
69510(k) clearances (0 in 12 months)
180recalls (3 in 12 months)
151recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 84 |
| CAC | Apparatus, Autotransfusion | 29 |
| GBZ | Catheter, Cholangiography | 25 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 21 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 20 |
| FTL | Mesh, Surgical, Polymeric | 19 |
| KDQ | Bottle, Collection, Vacuum | 19 |
| PAD | Chest Drainage Kit | 14 |
| JCT | Prosthesis, Tracheal, Expandable | 5 |
| DQY | Catheter, Percutaneous | 3 |
| DXE | Catheter, Embolectomy | 3 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 |
| PRL | Iliac Covered Stent, Arterial | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 |
| DWQ | Stripper, Vein, External | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2024 | K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft Atrium Medical Corporation | DSY |
| Sep 3, 2021 | K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Atrium Medical Corporation | CAC |
| Oct 22, 2015 | K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic Atrium Medical Corporation | FTL |
| Aug 27, 2015 | K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug Atrium Medical Corporation | FTL |
| Mar 15, 2013 | K130142 | FLIXENE IFG VASCULAR GRAFT Atrium Medical Corporation | DSY |
| Feb 28, 2013 | K130131 | EDRAIN CHEST DRAINAGE SYSTEM Atrium Medical Corp. | BTA |
| Aug 17, 2012 | K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT Atrium Medical Corp. | DSY |
| Apr 26, 2012 | K121070 | C-QUR RPM MESH Atrium Medical Corp. | FTL |
| Nov 17, 2011 | K113112 | CLEARWAY RX NB CATHETER Atrium Medical Corp. | DQY |
| Feb 15, 2011 | K110110 | ATRIUM CENTRILFX MESH Atrium Medical Corporation | FTL |
| Oct 5, 2010 | K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT Atrium Medical Corp. | DSY |
| Apr 20, 2010 | K093431 | CLEARWAY OTW MODEL 85912 Atrium Medical Corp. | DQY |
| Jan 26, 2010 | K100076 | ATRIUM C-QUR OVT MESH Atrium Medical Corp. | FTL |
| Jun 4, 2009 | K090909 | C-QUR V -PATCH MESH Atrium Medical Corp. | FTL |
| Jan 14, 2009 | K082748 | ATRIUM PROLITE S MESH Atrium Medical Corp. | FTL |
| Jul 25, 2008 | K081718 | EXPRESS CHEST DRAIN Atrium Medical Corp. | KDQ |
| Apr 16, 2008 | K080691 | C-QUR EDGE MESH V-PATCH Atrium Medical Corp. | FTL |
| Apr 16, 2008 | K080688 | C-QUR LITE MESH V-PATCH Atrium Medical Corp. | FTL |
| Aug 14, 2007 | K071923 | PTFE FLIXENE GRADUATED WALL GRAFT Atrium Medical Corp. | DSY |
| Mar 8, 2007 | K070192 | ATRIUM PROLITE ULTRA S MESH Atrium Medical Corp. | FTL |
| Dec 15, 2006 | K061680 | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER Atrium Medical Corp. | DQY |
| May 12, 2006 | K060396 | IVENA VASCULAR PATCH Atrium Medical Corp. | DXZ |
| Mar 31, 2006 | K050311 | ATRIUM MEDICAL CORPORATION C-QUR MESH Atrium Medical Corp. | FTL |
| Mar 30, 2006 | K060124 | ATRIUM FLIXENE GRAFT Atrium Medical Corp. | DSY |
| Sep 29, 2005 | K051332 | ADVANTA T-GRAFT Atrium Medical Corp. | DSY |
| May 6, 2005 | K050814 | ATRIUM ICAST COVERED STENT Atrium Medical Corp. | JCT |
| Jan 21, 2005 | K043582 | OCEAN CHEST DRAIN Atrium Medical Corp. | KDQ |
| Dec 8, 2004 | K043140 | EXPRESS AND OASIS CHEST DRAIN Atrium Medical Corp. | CAC |
| Sep 14, 2004 | K041269 | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT Atrium Medical Corp. | JCT |
| May 8, 2002 | K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER Atrium Medical Corp. | DXE |
| Apr 3, 2002 | K020767 | ADVANTA SST BIFURCATED GRAFT Atrium Medical Corp. | DSY |
| Jan 25, 2002 | K013577 | ULTRAMAX WOVEN VELOUR VASCULAR GRAFT Atrium Medical Corp. | DSY |
| May 18, 2001 | K010517 | ADVANTA SST GRAFT (<6MM) Atrium Medical Corp. | DSY |
| May 18, 2001 | K010516 | ADVANTA SST GRAFT (>_6MM) Atrium Medical Corp. | DSY |
| Apr 26, 2001 | K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER Atrium Medical Corp. | DXE |
| Jul 24, 2000 | K002093 | ATRIUM LITE MESH Atrium Medical Corp. | FTL |
| Mar 1, 2000 | K000504 | ADVANTA SUPER SOFT GRAFT Atrium Medical Corp. | DYF |
| Mar 1, 2000 | K000499 | ADVANTA SUPER SOFT GRAFT Atrium Medical Corp. | DSY |
| Jan 27, 2000 | K992991 | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT Atrium Medical Corp. | FTL |
| Nov 16, 1999 | K992776 | UNI-GRAFT K DV PATCH Atrium Medical Corp. | DXZ |
| Oct 1, 1999 | K992960 | ADVANTA GRAFT (>6MM) Atrium Medical Corp. | DSY |
| Oct 1, 1999 | K992958 | ADVANTA GRAFT (<6MM) Atrium Medical Corp. | DYF |
| Aug 20, 1999 | K992443 | ADVANTA GRAFT Atrium Medical Corp. | DSY |
| Aug 20, 1999 | K992441 | ADVANTA GRAFT Atrium Medical Corp. | DYF |
| Jun 1, 1999 | K991813 | UNI-GRAFT K DV VASCULAR GRAFT Atrium Medical Corp. | DSY |
| May 5, 1999 | K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN Atrium Medical Corp. | KDQ |
| Jul 21, 1997 | K963790 | UNI-GRAFT K DV Atrium Medical Corp. | DSY |
| Apr 13, 1995 | K950677 | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN Atrium Medical Corp. | KDQ |
| Dec 15, 1994 | K933391 | ATRIUM'S HYBRID PTFE Atrium Medical Corp. | DYF |
| Dec 16, 1993 | K930669 | ATRIUM POLYPROPYLENE MESH Atrium Medical Corp. | FTL |
Newest 50 of 69.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case;
Size(Model Number): 1. 28FR(15028), 2. 36FR(15036); Open, Classified |
GBZ | None listed |
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case;
Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136); Open, Classified |
GBZ | None listed |
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case;
Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036); Open, Classified |
GBZ | None listed |
| Oct 7, 2024 | Atrium Medical Corporation iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 Open, Classified |
PRL | None listed |
| 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, 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, 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 |
Newest 50 of 180.