Micro Therapeutics, Inc.
Medical device manufacturer in Irvine, CA.
51510(k) clearances
0PMA approvals
11recalls
Device types
- KRA Catheter, Continuous Flush 17
- HCG Device, Neurovascular Embolization 11
- MJN Catheter, Intravascular Occluding, Temporary 7
- DQX Wire, Guide, Catheter 6
- FOZ Catheter, Intravascular, Therapeutic… 4
- MCW Catheter, Peripheral, Atherectomy 2
- KRD Device, Vascular, For Promoting Embolization 2
- FMF Syringe, Piston 1
- DYB Introducer, Catheter 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K113289 | Orion Micro CatheterKRA · Traditional | 08/01/2012SE |
| K113454 | 14 Wire Standard, 14 Wire LSDQX · Traditional | 02/24/2012SE |
| K090870 | Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…KRA · Special | 05/01/2009SE |
| K090046 | Concerto Detachable Coil SystemKRD · Special | 02/27/2009SE |
| K081465 | Axium Detachable Coil SystemKRD · Traditional | 08/19/2008SE |
| K060747 | FX Detachable Coil SystemHCG · Traditional | 04/24/2007SE |
| K060625 | Nexus Detachable Coil System, Morpheus 3D CSRHCG · Special | 04/20/2006SE |
| K051990 | Echelon Micro CatheterKRA · Traditional | 01/04/2006SE |
| K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRHCG · Special | 06/28/2005SE |
| K051425 | Nexus Detachable Coil System, Helix Super Soft CSRHCG · Special | 06/22/2005SE |
| K050543 | Nexus Detachable Coil SystemHCG · Traditional | 04/27/2005SE |
| K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon…KRA · Special | 09/02/2004SE |
| K041649 | Sapphire NXT Detachable Coil SystemHCG · Special | 07/16/2004SE |
| K040694 | Modification to Sapphire Detachable Coil System (Tetris 3-D)HCG · Special | 03/25/2004SE |
| K034036 | Marathon Flow Directed Micro Catheter, Model 105-5055KRA · Traditional | 02/13/2004SE |
| K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple ModelsHCG · Traditional | 01/09/2004SE |
| K032497 | Sapphire VDS Tension Safe Detachable Coil, E-3-12/3-T10-VTHCG · Special | 09/25/2003SE |
| K031852 | Sapphire Detachable Fiber CoilsHCG · Traditional | 08/20/2003SE |
| K031992 | Echelon Micro Catheter, Model 105-5091KRA · Special | 08/07/2003SE |
| K030392 | Sapphire Detachable Coil SystemHCG · Traditional | 07/21/2003SE |
| K030688 | Echelon Micro Catheter, Model 105-5092-150KRA · Special | 03/28/2003SE |
| K024122 | Nautica Micro Catheter, Model 105-5094-153KRA · Traditional | 03/07/2003SE |
| K024118 | Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066KRA · Special | 02/03/2003SE |
| K022003 | Titan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305DYB · Traditional | 09/13/2002SE |
| K021066 | Modification to Hyperglide Occlusion Balloon SystemMJN · Traditional | 06/18/2002SE |
| K021139 | Truline Reinforced Valved Infusion CatheterFOZ · Special | 04/17/2002SE |
| K011937 | Truline Infusion CathetersFOZ · Special | 08/28/2001SE |
| K011535 | Cadence Precision Injector, Model 103-0304MJN · Abbreviated | 08/02/2001SE |
| K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771MJN · Special | 06/20/2001SE |
| K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126…MJN · Special | 06/14/2001SE |
| K010162 | Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026MJN · Traditional | 05/18/2001SE |
| K010497 | Silverspeed Hydrophilic Guidewire, Models 103-0601-300 and 103-0602-300DQX · Special | 03/22/2001SE |
| K010004 | Flowrider Flow Directed Micro Catheter, Model 105-5065KRA · Special | 02/13/2001SE |
| K002723 | Rebar Micro Catheter: REBAR-10 (1.7F), 153 CM, Dual Marker Bands; Rebar Micro Catheter:…KRA · Special | 09/28/2000SE |
| K002212 | Mirage Hydrophilic Guidewire, Model 103-0608DQX · Special | 08/03/2000SE |
| K001966 | Rebar Micro Catheter: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and…KRA · Special | 07/20/2000SE |
| K001454 | Silverspeed Hydrophilic Guidewire (0.014 Diameter, 145CM Length, Support) Silverspeed…DQX · Special | 06/07/2000SE |
| K001237 | Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM…MJN · Special | 05/18/2000SE |
| K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086KRA · Special | 01/04/2000SE |
| K993257 | .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016…DQX · Special | 10/21/1999SE |
| K990487 | Equinox Occlusion Balloon SystemMJN · Traditional | 08/31/1999SESK |
| K991225 | Mti 1 ML SyringeFMF · Abbreviated | 07/08/1999SE |
| K982543 | Silverstreak Hydrophilic GuidewireDQX · Traditional | 12/11/1998SE |
| K974473 | Easy Rider Micro CatheterKRA · Traditional | 06/17/1998SE |
| K980104 | Flow Rider Flow Directed Micro CatheterKRA · Traditional | 04/10/1998SE |
| K973669 | Thrombolytic Brush Catheter, Over the Wire (Otw)MCW · Traditional | 02/06/1998SE |
| K963925 | Thrombolytic Brush CatheterMCW · Traditional | 08/08/1997SE |
| K964868 | 2.9F Cragg-Mcnamara Valved Infusion CatheterKRA · Traditional | 05/20/1997SE |
| K953335 | Micro Therapeutics Variable Infusion Length CatheterFOZ · Traditional | 01/23/1996SE |
| K954020 | Micro Therapeutics Sidehole Infusion WireKRA · Traditional | 01/02/1996SE |
| K940634 | Micro Therapeutics Infusion CatheterFOZ · Traditional | 10/14/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2774-2026 Class II | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF…Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and… | 06/08/2026Open, Classified |
| Z-2773-2026 Class II | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF…Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and… | 06/08/2026Open, Classified |
| Z-1246-2025 Class I | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF:…Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall… | 01/30/2025Open, Classified |
| Z-1245-2025 Class I | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF:…Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall… | 01/30/2025Open, Classified |
| Z-1253-2024 Class II | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end…European version of microcatheter were distributed within US which contain a different "Indications for Use". | 01/11/2024Open, Classified |
| Z-1252-2024 Class II | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end…European version of microcatheter were distributed within US which contain a different "Indications for Use". | 01/11/2024Open, Classified |
| Z-1557-2022 Class II | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx OnlyOuter carton packaging of microcatheters were exposed to wet substance during transport. | 06/30/2022Open, Classified |
| Z-1556-2022 Class II | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx OnlyOuter carton packaging of microcatheters were exposed to wet substance during transport. | 06/30/2022Open, Classified |
| Z-1261-2022 Class II | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF…Due to incorrect size and configuration labeling of the detachable coil system. | 04/27/2022Open, Classified |
| Z-2403-2021 Class I | EV3 Pipeline Flex Embolization Device with Flex Shield TechnologyDue to potential push wire fractures in the delivery system during use. The issue presents as a fracture in… | 07/13/2021Open, Classified |
| Z-2402-2021 Class I | Pipeline Flex Embolization DeviceDue to potential push wire fractures in the delivery system during use. The issue presents as a fracture in… | 07/13/2021Open, Classified |