QFJ — Intravascular Bleed Monitor Class II

FDA Device Classification

Classification Details

Product Code: QFJ
Device Class: Class II
Regulation Number: 870.1345
Submission Type
Review Panel: CV
Medical Specialty: Cardiovascular
Implant: No

Definition

An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K230273	saranas	Saranas Early Bird Bleed Monitoring System	May 25, 2023
DEN180021	saranas	Early Bird Bleed Monitoring System	March 1, 2019