510(k) K071529 ยท QEZ Aspiration Thrombectomy Catheter
XTRACT CATHETER SYSTEM
| Applicant | Lumen Biomedical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 10, 2007 |
| Received | Jun 5, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2010 | Volcano Corporation Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user Terminated |
OGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.