510(k) K083837 ยท MCW Catheter, Peripheral, Atherectomy
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
| Applicant | Pathway Medical Technologies, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Jan 13, 2009 |
| Received | Dec 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083837
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.