OBI · Catheter, Pressure Monitoring, Cardiac
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | OBI |
|---|---|
| Device Name | Catheter, Pressure Monitoring, Cardiac |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | Sep 13, 2019 | SESE |
Top Applicants
- Acist Medical Systems, Inc. — 1 clearance
