SIF — Software Device System For Estimation Of Cardiac Pressures Class II
FDA product code SIF covers "Software Device System For Estimation Of Cardiac Pressures", a Class II medical device regulated under 21 CFR 870.1150. 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
- SIF
- Device Class
- Class II
- Regulation Number
- 870.1150
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250057 | cardiosense | PCWP Analysis Software | May 22, 2026 |