ClearanceBrief
510(k) K091641 ยท HCG Device, Neurovascular Embolization

HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)

ApplicantMicroVention, Inc., Aliso Viejo CA, US
DecisionSubstantially Equivalent, Jun 30, 2009
ReceivedJun 4, 2009
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K091641

DateFirm and productCodeLinked 510(k)
Nov 22, 2019Microvention, Inc.
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 1001
Terminated		 HCGNone listed
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 10
Terminated		 HCGNone listed
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HC
Terminated		 HCGNone listed
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S
Terminated		 HCGNone listed
Nov 22, 2019Microvention, Inc.
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V,
Terminated		 HCGNone listed
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS
Terminated		 HCGNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.