Product code OBI
- Device name
- Catheter, Pressure Monitoring, Cardiac
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1200
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To measure pressure within the cardiovascular system.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019-09-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841716103244 | ACIST Navvus®II Catheter | ACIST MEDICAL SYSTEMS, INC. | 2025-01-20 |
| 30841716102845 | RXi® Console Cable | ACIST MEDICAL SYSTEMS, INC. | 2021-06-17 |
| 10841716102483 | ACIST Navvus®II Catheter | ACIST MEDICAL SYSTEMS, INC. | 2020-05-12 |
| 30841716102692 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2020-05-12 |
| 10841716101738 | ACIST RXi® System | ACIST MEDICAL SYSTEMS, INC. | 2018-08-02 |
| 30841716101732 | ACIST RXi® System | ACIST MEDICAL SYSTEMS, INC. | 2018-08-02 |
| 30841716100360 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2017-08-17 |
| 30841716100377 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2017-08-17 |
| 10841716101448 | ACIST RXi® Ao Interface Box | ACIST MEDICAL SYSTEMS, INC. | 2016-12-08 |
| 30841716100469 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100414 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100476 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100483 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100490 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100506 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100513 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100520 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100537 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100544 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100551 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100452 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100445 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100438 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100421 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 10841716100588 | ACIST RXi® Bed Rail Mount | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100407 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100391 | RXi® Cable | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 30841716100384 | ACIST RXi® System | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 10841716101257 | ACIST RXi® System | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 10841716100595 | ACIST RXi® Cart | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |