Cleared Special

K220629 - Emerge Monorail PTCA Dilatation Catheter

K220629 is the FDA 510(k) clearance for Emerge Monorail PTCA Dilatation Catheter by Boston Scientific. It is a Class 2 Cardiovascular device (product code LOX) cleared through the Special 510(k) pathway after a 20-day FDA review.

K220629 · Boston Scientific · Cardiovascular device
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Mar 2022
Decision
20d
Days
Class 2
Risk

K220629 is an FDA 510(k) clearance for the Emerge Monorail PTCA Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Boston Scientific (Galway, IE). The FDA issued a Cleared decision on March 24, 2022 after a review of 20 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 devices

Submission Details

510(k) Number K220629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2022
Decision Date March 24, 2022
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
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 K220629.
SC HONKYTONK PTCA Balloon Dilatation Catheter
K223022 · Sino Medical Sciences Technology, Inc. · Feb 2023
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
K222538 · Sino Medical Sciences Technology, Inc. · Dec 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · Abbott Vascular · Jun 2022
OPN NC PTCA Dilatation Catheter
K212393 · Sis Medical AG · Mar 2022
Selebrek PTCA Balloon Dilatation Catheter
K211349 · Kossel Medtech (Suzhou) Co., Ltd. · Jan 2022
Sapphire NC 24
K211807 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Oct 2021