510(k) K133023 ยท MCW Catheter, Peripheral, Atherectomy
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
| Applicant | Medrad, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 27, 2014 |
| Received | Sep 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2017 | Boston Scientific Corporation The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.