The following data is part of a premarket notification filed by Inari Medical with the FDA for Clottriever Thrombectomy System.
Device ID | K182531 |
510k Number | K182531 |
Device Name: | ClotTriever Thrombectomy System |
Classification | Catheter, Embolectomy |
Applicant | Inari Medical 9272 Jeronimo Road Suite 124 Irvine, CA 92618 |
Contact | Eben Gordon |
Correspondent | Eben Gordon Inari Medical 9272 Jeronimo Road Suite 124 Irvine, CA 92618 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-14 |
Decision Date | 2018-10-10 |
Summary: | summary |