The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Swiftninja Microcatheter.
| Device ID | K161921 |
| 510k Number | K161921 |
| Device Name: | SwiftNINJA 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 | 2016-07-13 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450323878 | K161921 | 000 |
| 00884450297551 | K161921 | 000 |
| 00884450278505 | K161921 | 000 |
| 00884450324004 | K161921 | 000 |