510(k) K112404 ยท DQY Catheter, Percutaneous
CONCENTRIC BALLOON GUIDE CATHETER
| Applicant | Concentric Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 15, 2012 |
| Received | Aug 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112404
| 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.