OBI — Catheter, Pressure Monitoring, Cardiac Class II
FDA product code OBI covers "Catheter, Pressure Monitoring, Cardiac", a Class II medical device regulated under 21 CFR 870.1200. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OBI
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To measure pressure within the cardiovascular system.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190473 | acist medical systems | ACIST RXi System and Navvus II Catheter | September 13, 2019 |