Data / Medical devices / United States / Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Micro Therapeutics, Inc. Dba Ev3 Neurovascular: FDA-registered device maker in Irvine, CA, United States, 73 510(k) clearances and 2 PMA approvals
Micro Therapeutics, Inc. Dba Ev3 Neurovascular is registered with the FDA (registration 2029214) in Irvine, CA, United States. It lists 19 device types. The FDA files 73 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 24, 2026. 4 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2029214
- FEI number
- 1000220862
- Address
- 9775 Toledo Way, Irvine, CA, United States, 92618
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- November 12, 2008
- Registered through
- 2027
- Brand names listed
- 1 ml luer lock, 3G Detachable Coil System, APRO 45 Swift Catheter, APRO 55 Catheter and Alembic Aspiration Tubing, APRO 55 Intermediate Catheter, APRO 55 Swift Catheter And Alembic Aspiration Tubing, APRO 70 Catheter and Alembic Aspiration Tubing, APRO 70 Swift Catheter and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2026 | K261866 | Concerto Versa Detachable Coil | KRD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 14, 2026 | K253511 | Concerto Versa Detachable Coil | KRD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 30, 2025 | K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| April 29, 2025 | K250962 | APRO 55 Intermediate Catheter | DQY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| April 28, 2025 | K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| February 24, 2025 | K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| January 14, 2025 | K243297 | APRO 70 Swift Catheter | QJP | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| January 2, 2025 | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | QJP | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| December 2, 2024 | K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing | JCX | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| October 29, 2024 | K243080 | Riptide Aspiration System | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| May 28, 2024 | K241177 | React 71 Catheter | DQY | Substantially Equivalent | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | accessdata.fda.gov |
| March 15, 2024 | K234115 | APRO 55 Catheter | DQY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| February 29, 2024 | K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| November 7, 2023 | K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | HCG | Substantially Equivalent | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | accessdata.fda.gov |
| April 10, 2023 | K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| February 17, 2023 | K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | Alembic, LLC | accessdata.fda.gov |
| July 27, 2021 | K211990 | Rist 071 Radial Access Guide Catheter | DQY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 7, 2021 | K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| March 1, 2021 | K203358 | Solitaire X Revascularization Device | POL | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| February 16, 2021 | K210114 | Rebar Micro Catheter | KRA | Substantially Equivalent | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | accessdata.fda.gov |
| February 9, 2021 | K202850 | Concerto Versa, Detachable Coil | KRD | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| November 20, 2020 | K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | POL | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| September 28, 2020 | K201682 | RIST Radial Access Catheter | QJP | Substantially Equivalent | Rist Neurovascular, Inc. | accessdata.fda.gov |
| September 14, 2020 | K202318 | Marathon Flow Directed Micro Catheter | KRA | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 21, 2020 | K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | DQX | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 21, 2020 | K201689 | Riptide Aspiration System | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| May 2, 2020 | K200417 | RIST Radial Access Catheter | QJP | Substantially Equivalent | Rist Neurovascular, Inc. | accessdata.fda.gov |
| January 18, 2020 | K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire | DQX | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| December 23, 2019 | K191551 | RIST Cath Radial Access Long Sheath | DQY | Substantially Equivalent | Rist Neurovascular, Inc. | accessdata.fda.gov |
| March 6, 2019 | K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) | POL | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| January 29, 2019 | K183022 | Solitaire 4 Revascularization Device | POL | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| December 18, 2018 | K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System) | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| November 14, 2018 | K182101 | Riptide Aspiration System (React 71 Catheter) | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| November 14, 2018 | K182097 | React 71 Catheter | DQY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| October 25, 2018 | K181186 | Solitare Platinum Revascularization Device | POL | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 4, 2018 | K180715 | React 68 Catheter | DQY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 4, 2018 | K180705 | Riptide Aspiration System React 68 Catheter | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| June 11, 2018 | K180959 | Phenom 27 Catheter | DQY | Substantially Equivalent | Cathera, Inc. | accessdata.fda.gov |
| December 21, 2017 | K172448 | Riptide Aspiration System | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| March 8, 2017 | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| January 3, 2017 | K162704 | Axium Prime Detachable Coil System | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| November 10, 2016 | K162539 | Solitaire 2 Revascularization Device | POL | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| September 21, 2016 | K161879 | Solitaire Platinum Revascularization Device | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| December 23, 2015 | K153071 | Solitaire Platinum Revascularization Device | NRY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| November 13, 2015 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | DQY | Substantially Equivalent | Cathera, Inc. | accessdata.fda.gov |
| July 28, 2015 | K151447 | Axium Detachable Coil System | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| January 10, 2014 | K133310 | AXIUM DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| March 7, 2013 | K124007 | SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY | DQX | Substantially Equivalent | Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | accessdata.fda.gov |
| March 2, 2012 | K113455 | SOLITAIRE FR REVASCULARIZATION DEVICE | NRY | Substantially Equivalent | Micro Therapeutics Dba Ev3 Neurovascular | accessdata.fda.gov |
| February 24, 2012 | K113454 | 14 WIRE STANDARD, 14 WIRE LS | DQX | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| April 5, 2011 | K110055 | REVERSE MEDICAL REFLEX GUIDE CATHETER | DQY | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| July 13, 2010 | K101570 | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS | MJN | Substantially Equivalent | Micro Therapeutics Dba Ev3 Neurovascular | accessdata.fda.gov |
| February 2, 2010 | K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL | MJN | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| December 9, 2009 | K093750 | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA | KRA | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| October 15, 2009 | K091458 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 | MJN | Substantially Equivalent | Ev3 Neurovascular | accessdata.fda.gov |
| September 22, 2009 | K092495 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 | MJN | Substantially Equivalent | Ev3 Neurovascular | accessdata.fda.gov |
| September 18, 2009 | K091559 | MARKSMANN CATHETER | KRA | Substantially Equivalent | Chestnut Medical Technologies, Inc. | accessdata.fda.gov |
| April 16, 2009 | K090728 | HYPERGLIDE OCCLUSION BALLOON SYSTEM | MJN | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| February 27, 2009 | K090046 | CONCERTO DETACHABLE COIL SYSTEM | KRD | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| August 19, 2008 | K081465 | AXIUM DETACHABLE COIL SYSTEM | KRD | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| April 24, 2007 | K060747 | FX DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| January 4, 2006 | K051990 | ECHELON MICRO CATHETER | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| September 2, 2004 | K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| August 7, 2003 | K031992 | ECHELON MICRO CATHETER, MODEL 105-5091 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| March 28, 2003 | K030688 | ECHELON MICRO CATHETER, MODEL 105-5092-150 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| June 18, 2002 | K021066 | MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM | MJN | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| August 2, 2001 | K011535 | CADENCE PRECISION INJECTOR, MODEL 103-0304 | MJN | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| June 20, 2001 | K011656 | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 | MJN | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| August 3, 2000 | K002212 | MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 | DQX | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| July 20, 2000 | K001966 | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| June 7, 2000 | K001454 | SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D | DQX | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| January 4, 2000 | K993672 | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| July 8, 1999 | K991225 | MTI 1 ML SYRINGE | FMF | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 6, 2011 | P100018 | PIPELINE EMBOLIZATION DEVICE | OUT | 51 | July 21, 2026 | accessdata.fda.gov |
| July 21, 2005 | P030004 | ONYX LIQUID EMBOLIC SYSTEM | MFE | 41 | October 14, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | 99689 | Class II | Ongoing | Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire b | Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter. | accessdata.fda.gov |
| June 8, 2026 | 99326 | Class II | Ongoing | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. | accessdata.fda.gov |
| January 30, 2025 | 96168 | Class I | Ongoing | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027 | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in femal | accessdata.fda.gov |
| January 11, 2024 | 93922 | Class II | Ongoing | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a hi | European version of microcatheter were distributed within US which contain a different "Indications for Use". | accessdata.fda.gov |
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Updated September 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.