510(k) K993418 ยท HCG Device, Neurovascular Embolization
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
| Applicant | Boston Scientific, Target, Fremont CA, US |
| Decision | Substantially Equivalent, Jan 21, 2000 |
| Received | Oct 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2013 | Stryker Neurovascular Stryker brand GDC VORTX 2MM X 3MM, Catalog Number:
M00335302340; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior SL-10/ Terminated |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.