The following data is part of a premarket notification filed by Inari Medical with the FDA for Triever Catheters.
Device ID | K210195 |
510k Number | K210195 |
Device Name: | Triever Catheters |
Classification | Peripheral Mechanical Thrombectomy With Aspiration |
Applicant | Inari Medical 9 Parker, Suite 100 Irvine, CA 92618 |
Contact | Ellen Nguyen |
Correspondent | Ellen Nguyen Inari Medical 9 Parker, Suite 100 Irvine, CA 92618 |
Product Code | QEW |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-25 |
Decision Date | 2021-02-24 |