510(k) K042539 ยท HCG Device, Neurovascular Embolization
GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Oct 19, 2004 |
| Received | Sep 20, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042539
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2016 | Stryker Neurovascular GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil
Sterile;
Model number: M0033471020SR0;
Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because o Terminated |
HCG | None listed |
| Mar 21, 2016 | Stryker Neurovascular GDC-18 360 11MM X 30CM Detachable Coil
Sterile;
Model number: M0033471020SR0
Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms thata because of Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.