510(k) K232207

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

March 7, 2024

Date Received

July 26, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Catheter, Percutaneous, Cutting/Scoring

Device Class

Class II

Regulation Number

870.1250

Review Panel

CV

Submission Type

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material