Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

OMZ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250

Classification

FDA Product Code: OMZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1250
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 13

Source

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