510(k) K992958 ยท DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
ADVANTA GRAFT (<6MM)
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, Oct 1, 1999 |
| Received | Sep 2, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992958
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Jun 4, 2024 | Atrium Medical Corporation ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Open, Classified |
DYF | None listed |
| Sep 30, 2013 | Atrium Medical Corporation Advanta VXT Grafts <6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DYF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.