510(k) K082664 ยท MCW Catheter, Peripheral, Atherectomy
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
| Applicant | Pathway Medical Technologies, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Oct 6, 2008 |
| Received | Sep 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082664
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.