The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Solitaire 2 Revascularization Device.
Device ID | K162539 |
510k Number | K162539 |
Device Name: | Solitaire 2 Revascularization Device |
Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
Applicant | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
Contact | Jennifer Correa |
Correspondent | Jennifer Correa MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
Product Code | POL |
CFR Regulation Number | 882.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-12 |
Decision Date | 2016-11-10 |
Summary: | summary |