ClearanceBrief
Company ยท US

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2015. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
8recalls that name a 510(k)

Product codes

CodeDeviceRecords
OUTIntracranial Aneurysm Flow Diverter5
DQYCatheter, Percutaneous4
KRACatheter, Continuous Flush3
NRYCatheter, Thrombus Retriever3
HCGDevice, Neurovascular Embolization2
DQXWire, Guide, Catheter1
KRDDevice, Vascular, For Promoting Embolization1
MCWCatheter, Peripheral, Atherectomy1
MJNCatheter, Intravascular Occluding, Temporary1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 29, 2015K150107Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
Micro Therapeutics Inc Dba Ev3 Neurovascular
DQY
Nov 30, 2012K123378SOLITAIRE 2 REVASCULARIZATION DEVICE
Micro Therapeutics Dba Ev3 Neurovascular
NRY
Mar 2, 2012K113455SOLITAIRE FR REVASCULARIZATION DEVICE
Micro Therapeutics Dba Ev3 Neurovascular
NRY
Jul 13, 2010K101570HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
Micro Therapeutics Dba Ev3 Neurovascular
MJN

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 9, 2020Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Terminated
OUTNone listed
Mar 9, 2020Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Terminated
OUTNone listed
Aug 10, 2018Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Terminated
MCWK111723
May 16, 2018Micro Therapeutics Inc, Dba Ev3 Neurovascular
MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 30001
Terminated
NRYK141516
Nov 9, 2016Micro Therapeutics Inc, Dba Ev3 Neurovascular
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-06
Terminated
DQXNone listed
Nov 9, 2016Micro Therapeutics Inc, Dba Ev3 Neurovascular
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion o
Terminated
KRANone listed
Nov 9, 2016Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-8
Terminated
DQYNone listed
Nov 9, 2016Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) i
Terminated
OUTNone listed
Oct 14, 2015Micro Therapeutics Inc, Dba Ev3 Neurovascular
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. T
Terminated
OUTNone listed
Apr 16, 2014Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Terminated
DQYK043580
Apr 16, 2014Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Terminated
DQYNone listed
Aug 23, 2013Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneu
Terminated
OUTNone listed
Sep 27, 2012Micro Therapeutics Inc, Dba Ev3 Neurovascular
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selectiv
Terminated
KRAK034036
Sep 27, 2012Micro Therapeutics Inc, Dba Ev3 Neurovascular
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled s
Terminated
KRAK024118
Jan 26, 2012Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such a
Terminated
KRDK081465
Jan 26, 2012Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as
Terminated
HCGK060747
K081465
Jan 24, 2012Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque posit
Terminated
HCGK060747
Get alerts for these product codes