Cleared Special

K160823 - NC Quantum Apex PTCA Dilatation Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K160823 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
90d
Days
Class 2
Risk

K160823 is an FDA 510(k) clearance for the NC Quantum Apex 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 June 23, 2016 after a review of 90 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. 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. Standard predicate reliance. 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 K160823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date June 23, 2016
Days to Decision 90 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 85
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K160823.
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