510(k) K030475 ยท HCG Device, Neurovascular Embolization
GDC STRETCH RESISTANT DETACHABLE COIL
| Applicant | Boston Scientific, Target, Fremont CA, US |
| Decision | Substantially Equivalent, Mar 14, 2003 |
| Received | Feb 13, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2013 | Stryker Neurovascular Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number:
M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsio Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.