meddevicedb.com FDA Device Reference

Sapphire NC 24

K211807 Class II Traditional
Decision Date
2021-10-14
Sponsor / Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.

Technical Specification

510(k) Submission ID K211807
Product Code LOX
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5100
Decision Date 2021-10-14
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Sapphire NC 24 received FDA 510(k) clearance under submission number K211807, sponsored by OrbusNeich Medical (Shenzhen) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-10-14.

Classification & Regulation

This clearance is catalogued under FDA product code LOX and 21 CFR 870.5100, within the Cardiovascular review panel as a Class II device.