K173680 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 1, 2018 after a review of 90 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 Trading, Inc. devices
NCT03052530
Completed
Interventional
Industry-sponsored
Sapphire II PRO US Clinical Study
Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.
| Condition studied |
Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
David Kandzari, MD |
| Sponsor |
OrbusNeich
(industry)
|
Started 2017-05-05
→
Primary completion 2017-07-24
Primary outcome
Number of Participants With Device Procedural Success
Secondary outcome
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
View full study on ClinicalTrials.gov