510(k) K103355 ยท HCG Device, Neurovascular Embolization
GDC 360 DETEACHABLE COIL
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Feb 16, 2011 |
| Received | Nov 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Stryker Neurovascular GDC-10 360 SOFT 3mm x 6cm SR ;
GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's
general medi Terminated |
HCG | None listed |
| Dec 16, 2014 | Stryker Neurovascular GDC-10 360 10mm x 30cm SR ;
GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's
general medical Terminated |
HCG | None listed |
| Dec 16, 2014 | Stryker Neurovascular GDC-18 360 20mm x 33cm ;
GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's
general medical co Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.