Cleared Traditional

K160961 - Mozec NC-Rx PTCA Baloon Dilatation Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160961 · Meril Life Sciences Private Limited · Cardiovascular device
Jul 2016
Decision
116d
Days
Class 2
Risk

K160961 is an FDA 510(k) clearance for the Mozec NC-Rx PTCA Baloon Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Meril Life Sciences Private Limited (Vapi, IN). The FDA issued a Cleared decision on July 30, 2016 after a review of 116 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.

Submission Details

510(k) Number K160961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date July 30, 2016
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 140d · This submission: 116d
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

Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K160961.
Ryurei
K252295 · Terumo Corporation · Mar 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · Medtronic, Ireland · Jan 2026
Pantera Pro
K242969 · Biotronik, Inc. · Oct 2024
NC TREK NEO Coronary Dilatation Catheter
K220634 · Abbott Vascular · Jun 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · Boston Scientific · Mar 2022