Atrium Medical Corporation
Merrimack, NH, US
Atrium Medical Corporation appears in FDA device records in Merrimack, NH. FDA records list 69 510(k) clearances between and , 12 PMA records and one registered establishment. As of , FDA records show 177 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 69FDA records hold 69 510(k) clearances for Atrium Medical Corporation between 1981 and 2024. The busiest year on record is 1999, with 7. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1985 | 2 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 6 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1999 | 7 |
| 2000 | 4 |
| 2001 | 3 |
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 2 |
| 2015 | 2 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | DSY | Substantially Equivalent | |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | CAC | Substantially Equivalent | |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic | FTL | Substantially Equivalent | |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | FTL | Substantially Equivalent | |
| K130142 | FLIXENE IFG VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | BTA | Substantially Equivalent | |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K121070 | C-QUR RPM MESH | FTL | Substantially Equivalent | |
| K113112 | CLEARWAY RX NB CATHETER | DQY | Substantially Equivalent | |
| K110110 | ATRIUM CENTRILFX MESH | FTL | Substantially Equivalent | |
| K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT | DSY | Substantially Equivalent | |
| K093431 | CLEARWAY OTW MODEL 85912 | DQY | Substantially Equivalent | |
| K100076 | ATRIUM C-QUR OVT MESH | FTL | Substantially Equivalent | |
| K090909 | C-QUR V -PATCH MESH | FTL | Substantially Equivalent | |
| K082748 | ATRIUM PROLITE S MESH | FTL | Substantially Equivalent | |
| K081718 | EXPRESS CHEST DRAIN | KDQ | Substantially Equivalent | |
| K080691 | C-QUR EDGE MESH V-PATCH | FTL | Substantially Equivalent | |
| K080688 | C-QUR LITE MESH V-PATCH | FTL | Substantially Equivalent | |
| K071923 | PTFE FLIXENE GRADUATED WALL GRAFT | DSY | Substantially Equivalent | |
| K070192 | ATRIUM PROLITE ULTRA S MESH | FTL | Substantially Equivalent | |
| K061680 | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER | DQY | Substantially Equivalent | |
| K060396 | IVENA VASCULAR PATCH | DXZ | Substantially Equivalent | |
| K050311 | ATRIUM MEDICAL CORPORATION C-QUR MESH | FTL | Substantially Equivalent | |
| K060124 | ATRIUM FLIXENE GRAFT | DSY | Substantially Equivalent | |
| K051332 | ADVANTA T-GRAFT | DSY | Substantially Equivalent | |
| K050814 | ATRIUM ICAST COVERED STENT | JCT | Substantially Equivalent | |
| K043582 | OCEAN CHEST DRAIN | KDQ | Substantially Equivalent | |
| K043140 | EXPRESS AND OASIS CHEST DRAIN | CAC | Substantially Equivalent | |
| K041269 | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | JCT | Substantially Equivalent | |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | DXE | Substantially Equivalent | |
| K020767 | ADVANTA SST BIFURCATED GRAFT | DSY | Substantially Equivalent | |
| K013577 | ULTRAMAX WOVEN VELOUR VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K010517 | ADVANTA SST GRAFT (<6MM) | DSY | Substantially Equivalent | |
| K010516 | ADVANTA SST GRAFT (>_6MM) | DSY | Substantially Equivalent | |
| K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | DXE | Substantially Equivalent | |
| K002093 | ATRIUM LITE MESH | FTL | Substantially Equivalent | |
| K000504 | ADVANTA SUPER SOFT GRAFT | DYF | Substantially Equivalent | |
| K000499 | ADVANTA SUPER SOFT GRAFT | DSY | Substantially Equivalent | |
| K992991 | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT | FTL | Substantially Equivalent | |
| K992776 | UNI-GRAFT K DV PATCH | DXZ | Substantially Equivalent | |
| K992960 | ADVANTA GRAFT (>6MM) | DSY | Substantially Equivalent | |
| K992958 | ADVANTA GRAFT (<6MM) | DYF | Substantially Equivalent | |
| K992443 | ADVANTA GRAFT | DSY | Substantially Equivalent | |
| K992441 | ADVANTA GRAFT | DYF | Substantially Equivalent | |
| K991813 | UNI-GRAFT K DV VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN | KDQ | Substantially Equivalent | |
| K963790 | UNI-GRAFT K DV | DSY | Substantially Equivalent | |
| K950677 | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN | KDQ | Substantially Equivalent | |
| K933391 | ATRIUM'S HYBRID PTFE | DYF | Unknown | |
| K930669 | ATRIUM POLYPROPYLENE MESH | FTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011175548 | 3011175548 | Atrium Medical Corporation | 40 Continental Blvd, Merrimack, NH 03054 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- CACApparatus, Autotransfusion
- KDQBottle, Collection, Vacuum
- GBZCatheter, Cholangiography
- DXECatheter, Embolectomy
- DQYCatheter, Percutaneous
- GBSCatheter, Ventricular, General & Plastic Surgery
- PRLIliac Covered Stent, Arterial
- DWSInstruments, Surgical, Cardiovascular
- FTLMesh, Surgical, Polymeric
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- JCTProsthesis, Tracheal, Expandable
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- BTAPump, Portable, Aspiration (Manual Or Powered)
- DWQStripper, Vein, External
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
Recall records
Showing 25 of 177| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0024-2025 | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. | Class II | Open, Classified | |
| Z-2018-2024 | FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2017-2024 | FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2016-2024 | FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2015-2024 | FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2014-2024 | FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2013-2024 | FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2012-2024 | FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2011-2024 | FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2010-2024 | FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2009-2024 | FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2008-2024 | FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2007-2024 | FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2006-2024 | FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2005-2024 | FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2004-2024 | FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2003-2024 | FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2002-2024 | FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2001-2024 | ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-2000-2024 | ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-1999-2024 | ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-1998-2024 | ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-1997-2024 | ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-1996-2024 | ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified | |
| Z-1995-2024 | ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain