510(k) K060124 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
ATRIUM FLIXENE GRAFT
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, Mar 30, 2006 |
| Received | Jan 18, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Jun 4, 2024 | Atrium Medical Corporation FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Open, Classified |
DSY | None listed |
| Sep 30, 2013 | Atrium Medical Corporation Flixene Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.