PFA — Non-Invasive Central Venous Manometer Class II
FDA product code PFA covers "Non-Invasive Central Venous Manometer", a Class II medical device regulated under 21 CFR 870.1140. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PFA
- Device Class
- Class II
- Regulation Number
- 870.1140
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.