Catheters, Transluminal Coronary Angioplasty, Percutaneous

LOX · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5100

Classification

FDA Product Code: LOX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.5100
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Market data

Cleared 510(k) submissions: 86
Registered establishments: 72

Source

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