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STEALTH 360 ORBITAL PAD SYSTEM

K110389 Class II Special
Decision Date
2011-03-11
Sponsor / Applicant
Cardiovascular Systems, Inc.

Technical Specification

510(k) Submission ID K110389
Product Code MCW
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4875
Decision Date 2011-03-11
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

STEALTH 360 ORBITAL PAD SYSTEM received FDA 510(k) clearance under submission number K110389, sponsored by Cardiovascular Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-03-11.

Classification & Regulation

This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.