The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Infusion Aspiration Catheter System.
| Device ID | K143563 |
| 510k Number | K143563 |
| Device Name: | Infusion Aspiration Catheter System |
| Classification | Catheter, Embolectomy |
| Applicant | Inari Medical, Inc. 8 Argonaut Suite 100 Aliso Vejo, CA 92656 |
| Contact | Eben Gordon |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-12-16 |
| Decision Date | 2015-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850291007062 | K143563 | 000 |
| 00850291007055 | K143563 | 000 |
| 00850291007048 | K143563 | 000 |
| 00850291007031 | K143563 | 000 |
| 00850291007024 | K143563 | 000 |
| 00850291007017 | K143563 | 000 |
| 00850291007000 | K143563 | 000 |