Cleared Traditional

RX Takeru Balloon Dilatation Catheter (K163372) - FDA 510(k) Clearance

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

K163372 · KANEKA Corporation · Cardiovascular device
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Apr 2017
Decision
127d
Days
Class 2
Risk

K163372 is an FDA 510(k) clearance for the RX Takeru Balloon Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by KANEKA Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 7, 2017 after a review of 127 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.

View all KANEKA Corporation devices

Submission Details

510(k) Number K163372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2016
Decision Date April 07, 2017
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
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

All 47
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K163372.
OTW Takeru PTCA Balloon Dilatation Catheter
K172264 · KANEKA Corporation · Mar 2018
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
Emerge PTCA Dilatation Catheter
K163174 · Boston Scientific Corporation · Dec 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
K163200 · Boston Scientific Corporation · Dec 2016