meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code SIF — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.1150

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN250057 PCWP Analysis Software Cardiosense, Inc. 2026-05-22 Direct —

Product code SIF · Class II · Cardiovascular. Data: openFDA.