Cleared Traditional

Sapphire NC ULTRA Coronary Dilatation Catheter

K233499 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Cardiovascular
Aug 2024
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K233499 is an FDA 510(k) clearance for the Sapphire NC ULTRA Coronary Dilatation Catheter, 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 August 16, 2024, 290 days after receiving the submission on October 31, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K233499 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2023
Decision Date August 16, 2024
Days to Decision 290 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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