Tubing, Long Term Support Greater Than 6 Hours

QWF · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4100

Classification

FDA Product Code: QWF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.4100
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 6

Source

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