Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

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

Classification

FDA Product Code: NWX
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

To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 12

Source

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