ClearanceBrief
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

CodeDeviceRecords
HGCClamp, Uterine10

Latest 510(k) clearances

Decided510(k)Device and applicantCode
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Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
Jan 5, 2011Boston 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
HGCK012985
K031168
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