Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

QRJ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5125

Classification

FDA Product Code: QRJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.5125
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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