The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Intri24 Sheath.
| Device ID | K212392 |
| 510k Number | K212392 |
| Device Name: | Intri24 Sheath |
| Classification | Introducer, Catheter |
| Applicant | Inari Medical, Inc. 9 Parker, Suite 100 Irvine, CA 92618 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan Inari Medical, Inc. 9 Parker, Suite 100 Irvine, CA 92618 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850291007260 | K212392 | 000 |