The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Rxi System And Navvus Ii Catheter.
| Device ID | K190473 |
| 510k Number | K190473 |
| Device Name: | ACIST RXi System And Navvus II Catheter |
| Classification | Catheter, Pressure Monitoring, Cardiac |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Contact | Sherri Mellingen |
| Correspondent | Sherri Mellingen ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Product Code | OBI |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-09-13 |
| Summary: | summary |