The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Cardiovascular Pressure Measurement (cpm) System, Navvus Catheter.
| Device ID | K132474 |
| 510k Number | K132474 |
| Device Name: | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | ACIST MEDICAL SYSTEMS 7905 FULLER ROAD Eden Prairie, MN 55344 |
| Contact | Matthew Stepanek |
| Correspondent | Matthew Stepanek ACIST MEDICAL SYSTEMS 7905 FULLER ROAD Eden Prairie, MN 55344 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2014-01-30 |
| Summary: | summary |