510(k) K012985 ยท HCG Device, Neurovascular Embolization
MATRIX DETACHABLE COILS
| Applicant | Boston Scientific, Target, Fremont CA, US |
| Decision | Substantially Equivalent, Jan 31, 2002 |
| Received | Sep 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 360 Soft SR Coils.
Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 Helical UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
| Jan 5, 2011 | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.