FDA 510(k) Applications Submitted by MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K141516 |
06/09/2014 |
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K133310 |
10/28/2013 |
AXIUM DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K203432 |
11/23/2020 |
Axium Detachable Coil; Axium Prime Detachable Coil |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K202318 |
08/17/2020 |
Marathon Flow Directed Micro Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K183022 |
11/01/2018 |
Solitaire 4 Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K193576 |
12/23/2019 |
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K161152 |
04/25/2016 |
Navien Intracranial Support Catheter |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K181807 |
07/06/2018 |
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K162539 |
09/12/2016 |
Solitaire 2 Revascularization Device |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K162704 |
09/28/2016 |
Axium Prime Detachable Coil System |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K201689 |
06/22/2020 |
Riptide Aspiration System |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K141491 |
06/05/2014 |
SOLITAIRE 2 REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K183185 |
11/19/2018 |
Riptide Aspiration System (Riptide Large Bore Aspiration System) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K151447 |
05/29/2015 |
Axium Detachable Coil System |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K153071 |
10/22/2015 |
Solitaire Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K201690 |
06/22/2020 |
Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K202850 |
09/28/2020 |
Concerto Versa, Detachable Coil |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K160641 |
03/07/2016 |
Solitaire Platinum Revascularization Device, 6x40 mm |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K180705 |
03/19/2018 |
Riptide Aspiration System React 68 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K180715 |
03/19/2018 |
React 68 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K181186 |
05/03/2018 |
Solitare Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K161879 |
07/08/2016 |
Solitaire Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K182097 |
08/03/2018 |
React 71 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K182101 |
08/03/2018 |
Riptide Aspiration System (React 71 Catheter) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K193548 |
12/20/2019 |
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
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