The following data is part of a premarket notification filed by Inari Medical with the FDA for Flowtriever Retrieval/aspiration System, Aspiration Guide Catheter.
Device ID | K173672 |
510k Number | K173672 |
Device Name: | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter |
Classification | Catheter, Embolectomy |
Applicant | Inari Medical 9272 Jeronimo Rd., Suite 124 Irvine, CA 92618 |
Contact | Eben Gordon |
Correspondent | Eben Gordon Inari Medical 9272 Jeronimo Rd., 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 | 2017-11-30 |
Decision Date | 2018-02-05 |
Summary: | summary |