Cleared Traditional

K211807 - Sapphire NC 24

K211807 is an FDA 510(k) clearance for Sapphire NC 24, manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 125-day FDA review.

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

K211807 is an FDA 510(k) clearance for the Sapphire NC 24. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 14, 2021 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all OrbusNeich Medical (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K211807

510(k) Number K211807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOX Device Classification - Class 2, Special Controls

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 51
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K211807.
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Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · Kossel Medtech (Suzhou) Co., Ltd. · Jul 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · Medcaptain Life Science Co., Ltd. · May 2021