The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Swiftninja Steerable Microcatheter.
| Device ID | K211525 |
| 510k Number | K211525 |
| Device Name: | SwiftNINJA Steerable Microcatheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Luke Meidell |
| Correspondent | Luke Meidell Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2021-07-16 |