Intravascular Bleed Monitor

QFJ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1345

Classification

FDA Product Code: QFJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1345
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown