K130391 is an FDA 510(k) clearance for the EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATIO.... Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on July 10, 2013 after a review of 145 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.
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NCT01635881
Completed
Interventional
Industry-sponsored
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
EMERGE: Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter
| Condition studied |
Coronary Artery Disease |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
David E Kandzari, MD |
| Sponsor |
Boston Scientific Corporation
(industry)
|
Started 2012-07-01
→
Primary completion 2012-12-01
Primary outcome
Device Procedural Success
Secondary outcome
In-hospital Major Adverse Cardiac Events (MACE)
View full study on ClinicalTrials.gov