QFJ

Intravascular Bleed Monitor

Product code

QFJ

Device name

Intravascular Bleed Monitor

Device class

Class 2

21 CFR

21 CFR 870.1345

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).