510(k) K052964 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 6, 2006 |
| Received | Oct 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2010 | Maquet Cardiovascular, LLC EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight.
Sterile
Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace perip Terminated |
DSY | None listed |
| May 14, 2010 | Maquet Cardiovascular, LLC EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight.
Sterile
Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripher Terminated |
DSY | None listed |
| Feb 26, 2010 | Maquet Cardiovascular, LLC EXXCEL Soft Standard Wall EPTFE Vascular Graft;
D:8 mm: L: 50 mm straight
Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470 Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.