510(k) K110389 ยท MCW Catheter, Peripheral, Atherectomy
STEALTH 360 ORBITAL PAD SYSTEM
| Applicant | Cardiovascular Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Mar 11, 2011 |
| Received | Feb 10, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2012 | Cardiovascular Systems, Inc. CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.