FDA Product Code MCW: Catheter, Peripheral, Atherectomy
Peripheral artery disease caused by atherosclerotic plaque can be treated by directly removing the obstruction. FDA product code MCW covers peripheral atherectomy catheters.
These devices use rotating blades, laser energy, or orbital abrasion to debulk atherosclerotic plaque from peripheral arteries, restoring blood flow without the vessel stretching associated with balloon angioplasty. They are used in the treatment of femoral, popliteal, and tibial artery disease.
MCW devices are Class II medical devices, regulated under 21 CFR 870.4875 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Cardio Flow Inc.,, Cardiovascular Systems, Inc. and Avinger, Inc..
FDA 510(k) Cleared Catheter, Peripheral, Atherectomy Devices (Product Code MCW)
About Product Code MCW - Regulatory Context
510(k) Submission Activity
146 total 510(k) submissions under product code MCW since 1990, with 146 receiving FDA clearance (average review time: 102 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under MCW have taken an average of 60 days to reach a decision - down from 104 days historically, suggesting improved FDA processing for this classification.
MCW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →