Cardiac Ablation Percutaneous Catheter

LPB · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: LPB
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].

Market data

Cleared 510(k) submissions: 0
Registered establishments: 55

Source

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