Cleared Special

K163174 - Emerge PTCA Dilatation Catheter

K163174 is the FDA 510(k) clearance for Emerge PTCA Dilatation Catheter by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code LOX) cleared through the Special 510(k) pathway after a 30-day FDA review.

K163174 · Boston Scientific Corporation · Cardiovascular device
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Dec 2016
Decision
30d
Days
Class 2
Risk

K163174 is an FDA 510(k) clearance for the Emerge PTCA Dilatation Catheter. 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 December 14, 2016 after a review of 30 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K163174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date December 14, 2016
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K163174.
Sapphire II PRO
K173680 · Orbusneich Medical Trading, Inc. · Mar 2018
Gallant PTCA Dilatation Catheter
K173581 · Medinol, Ltd. · Jan 2018
Pantera LEO
K163660 · Biotronik, Inc. · Jan 2017
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
K163200 · Boston Scientific Corporation · Dec 2016
Pantera Pro
K160985 · Biotronik, Inc. · Oct 2016
NC Quantum Apex PTCA Dilatation Catheter
K160823 · Boston Scientific Corporation · Jun 2016