Product code SIF— Cardiovascular
PCWP Analysis Software
- Classification name
- Software Device System For Estimation Of Cardiac Pressures
- Device class
- Class 2
- Regulation
- 21 CFR 870.1150
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SIF
FDA has cleared device under product code SIF, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SIF
Recent clearances under product code SIF
Data sourced from openFDA. This site is unofficial and independent of the FDA.