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
| Code | Device | Records |
|---|---|---|
| OUT | Intracranial Aneurysm Flow Diverter | 5 |
| DQY | Catheter, Percutaneous | 4 |
| KRA | Catheter, Continuous Flush | 3 |
| NRY | Catheter, Thrombus Retriever | 3 |
| HCG | Device, Neurovascular Embolization | 2 |
| DQX | Wire, Guide, Catheter | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 |
| MCW | Catheter, Peripheral, Atherectomy | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2015 | K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter Micro Therapeutics Inc Dba Ev3 Neurovascular | DQY |
| Nov 30, 2012 | K123378 | SOLITAIRE 2 REVASCULARIZATION DEVICE Micro Therapeutics Dba Ev3 Neurovascular | NRY |
| Mar 2, 2012 | K113455 | SOLITAIRE FR REVASCULARIZATION DEVICE Micro Therapeutics Dba Ev3 Neurovascular | NRY |
| Jul 13, 2010 | K101570 | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS Micro Therapeutics Dba Ev3 Neurovascular | MJN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2020 | Micro Therapeutics Inc, Dba Ev3 Neurovascular ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use. Terminated |
OUT | None listed |
| Mar 9, 2020 | Micro Therapeutics Inc, Dba Ev3 Neurovascular ev3 Pipeline Flex Embolization Device. For neurological endovascular use. Terminated |
OUT | None listed |
| Aug 10, 2018 | Micro 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 |
MCW | K111723 |
| May 16, 2018 | Micro 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 |
NRY | K141516 |
| Nov 9, 2016 | Micro 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 |
DQX | None listed |
| Nov 9, 2016 | Micro 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 |
KRA | None listed |
| Nov 9, 2016 | Micro 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 |
DQY | None listed |
| Nov 9, 2016 | Micro 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 |
OUT | None listed |
| Oct 14, 2015 | Micro 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 |
OUT | None listed |
| Apr 16, 2014 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal. Terminated |
DQY | K043580 |
| Apr 16, 2014 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. Terminated |
DQY | None listed |
| Aug 23, 2013 | Micro 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 |
OUT | None listed |
| Sep 27, 2012 | Micro 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 |
KRA | K034036 |
| Sep 27, 2012 | Micro 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 |
KRA | K024118 |
| Jan 26, 2012 | Micro 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 |
KRD | K081465 |
| Jan 26, 2012 | Micro 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 |
HCG | K060747 K081465 |
| Jan 24, 2012 | Micro 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 |
HCG | K060747 |