510(k) K082199 ยท QEY Mechanical Thrombolysis Catheter
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
| Applicant | Bacchus Vascular, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Aug 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082199
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.