510(k) K013789 ยท DQY Catheter, Percutaneous
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
| Applicant | Boston Scientific, Target, Fremont CA, US |
| Decision | Substantially Equivalent, Dec 6, 2001 |
| Received | Nov 14, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsio Terminated |
DQY | None listed |
| Oct 7, 2008 | Boston Scientific Corporation Excelsior SL-10 Microcatheter, placed in sterile pouch. Manufactured by Boston Scientific Corporation, Fremont, CA.
The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagn Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.