Cleared Traditional

K131169 - MOZEC - RX PTCA BALLOON DILATATION CATHETER

K131169 is an FDA 510(k) clearance for MOZEC - RX PTCA BALLOON DILATATION CATHETER, manufactured by Meril Life Sciences Private Limited. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K131169 · Meril Life Sciences Private Limited · Cardiovascular device
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Dec 2013
Decision
244d
Days
Class 2
Risk

K131169 is an FDA 510(k) clearance for the MOZEC - RX PTCA BALLOON DILATATION CATHETER. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Meril Life Sciences Private Limited (Baltimore, US). The FDA issued a Cleared decision on December 24, 2013 after a review of 244 days - an extended review 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: 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.

View all Meril Life Sciences Private Limited devices

FDA 510(k) Submission Details - K131169

510(k) Number K131169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date December 24, 2013
Days to Decision 244 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
119d slower than avg
Panel avg: 125d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOX Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K131169.
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K141236 · Boston Scientific Corporation · Aug 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
K134031 · Boston Scientific Corporation · Jul 2014
CHOCOLATE PTCA BOLLOON CATHETER
K133633 · Trireme Medical, Inc. · Jun 2014
HOPER PTCA BALLOON CATHETER
K123473 · Lepu Medical Technology (Beijing) Co., Ltd. · Aug 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0
K131450 · Ostial Corporation · Aug 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
K130391 · Boston Scientific Corp · Jul 2013