510(k) K101221 ยท MCW Catheter, Peripheral, Atherectomy
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
| Applicant | Pathway Medical Technologies, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Jun 2, 2010 |
| Received | May 3, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101221
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.