510(k) K093918 ยท MCW Catheter, Peripheral, Atherectomy
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
| Applicant | Pathway Medical Technologies, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Jan 21, 2010 |
| Received | Dec 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093918
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.