510(k) K210282 ยท NTE Temporary Carotid Catheter For Embolic Capture
WIRION Embolic Protection System
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Mar 3, 2021 |
| Received | Feb 1, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2021 | Cardiovascular Systems Inc WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 Terminated |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.