Company
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGC | Clamp, Uterine | 10 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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 360 UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Terminated |
HGC | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |
| 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 | K012985 K031168 |