The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Solitaire 4 Revascularization Device.
Device ID | K183022 |
510k Number | K183022 |
Device Name: | Solitaire 4 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 | Helen Chow |
Correspondent | Helen Chow 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 | 2018-11-01 |
Decision Date | 2019-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00763000425739 | K183022 | 000 |
00763000425715 | K183022 | 000 |
00763000425692 | K183022 | 000 |
00763000425678 | K183022 | 000 |
00763000425654 | K183022 | 000 |
00763000425630 | K183022 | 000 |