Cleared Special

K200269 - Sapphire II PRO

K200269 is the FDA 510(k) clearance for Sapphire II PRO by Orbusneich Medical Trading, Inc.. It is a Class 2 Cardiovascular device (product code LOX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K200269 · Orbusneich Medical Trading, Inc. · Cardiovascular device
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Mar 2020
Decision
29d
Days
Class 2
Risk

K200269 is an FDA 510(k) clearance for the Sapphire II PRO. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Orbusneich Medical Trading, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on March 4, 2020 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orbusneich Medical Trading, Inc. devices

Submission Details

510(k) Number K200269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2020
Decision Date March 04, 2020
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 47
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K200269.
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