Cleared Traditional

Sapphire NC 24

K211807 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Cardiovascular
Oct 2021
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K211807 is an FDA 510(k) clearance for the Sapphire NC 24, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 14, 2021, 125 days after receiving the submission on June 11, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K211807 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2021
Decision Date October 14, 2021
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.

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