Cleared Traditional

K141236 - NC EMERGE PTCA DILATATION CATHETER (MON...

K141236 is the FDA 510(k) clearance for NC EMERGE PTCA DILATATION CATHETER (MON... by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code LOX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K141236 · Boston Scientific Corporation · Cardiovascular device
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Aug 2014
Decision
86d
Days
Class 2
Risk

K141236 is an FDA 510(k) clearance for the NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATH.... Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K141236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2014
Decision Date August 07, 2014
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K141236.
NC Quantum Apex PTCA Dilatation Catheter
K160823 · Boston Scientific Corporation · Jun 2016
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · Medtronic, Inc. · Apr 2015
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · Medtronic, Inc. · Aug 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
K134031 · Boston Scientific Corporation · Jul 2014
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
K130391 · Boston Scientific Corp · Jul 2013
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K121196 · Boston Scientific Corp · Aug 2012