Cleared Traditional

K130391 - EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT

K130391 is an FDA 510(k) clearance for EMERGE MONORAIL PTCA DILATATION CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K130391 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
145d
Days
Class 2
Risk

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.

FDA 510(k) Submission Details - K130391

510(k) Number K130391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2013
Decision Date July 10, 2013
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
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

60
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
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

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 86
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K130391.
MOZEC - RX PTCA BALLOON DILATATION CATHETER
K131169 · Meril Life Sciences Private Limited · Dec 2013
HOPER PTCA BALLOON CATHETER
K123473 · Lepu Medical Technology (Beijing) Co., Ltd. · Aug 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0
K131450 · Ostial Corporation · Aug 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
K123279 · Abbott Vascular · Jan 2013
DK-PTCA BALLOON CATHETER
K123264 · Intuit Medical, LLC · Jan 2013
TAMARIN BLUE PTCA RX DILATATION CATHETER
K112735 · Natec Medical , Ltd. · Nov 2012
K130391 · EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
Download PDF FDA Summary Boston Scientific Corp