510(k) K010954 ยท DQY Catheter, Percutaneous
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
| Applicant | Concentric Medical, Inc., Moutian View CA, US |
| Decision | Substantially Equivalent, Oct 9, 2001 |
| Received | Mar 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2018 | Stryker Neurovascular Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.