OBI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Pressure Monitoring, Cardiac
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- FDA definition
- To measure pressure within the cardiovascular system.
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| Record | Firm | Date |
|---|---|---|
| ACIST RXi System and Navvus II Catheter (K190473) | Acist Medical Systems, Inc. | 2019-09-13 |
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Every clearance here is in the API, with alerts when new ones post.