510(k) K152694 ยท MCW Catheter, Peripheral, Atherectomy
Diamondback 360 Peripheral Orbital Atherectomy System
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Oct 21, 2015 |
| Received | Sep 21, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2017 | Cardiovascular Systems Inc Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acce Terminated |
MCW | None listed |
| Sep 14, 2017 | Cardiovascular Systems Inc Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acce Terminated |
MCW | None listed |
| Feb 22, 2017 | Cardiovascular Systems Inc DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145
Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patien Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.