NWXClass III

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

Unknown

NWX is the FDA product code for Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring, a class III device type. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code: NWX
Device name: Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA 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.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 3

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NWX

FDA records hold no clearances under product code NWX.

Recent recalls

Product code NWX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)