Cleared Special

OTW Takeru PTCA Balloon Dilatation Catheter (K172264) - FDA 510(k) Clearance

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

K172264 · KANEKA Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
235d
Days
Class 2
Risk

K172264 is an FDA 510(k) clearance for the OTW Takeru PTCA 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 March 19, 2018 after a review of 235 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. 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 KANEKA Corporation devices

Submission Details

510(k) Number K172264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2017
Decision Date March 19, 2018
Days to Decision 235 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
110d slower than avg
Panel avg: 125d · This submission: 235d
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 Consultant

Quintilesims
Christopher M. Sloan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 46
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K172264.
NC TREK™ RX Coronary Dilatation Catheter
K180040 · Abbott Vascular · Aug 2018
Sapphire II PRO Balloon Dilatation Catheter
K180921 · Orbusneich Medical Trading, Inc. · Jun 2018
Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
K181023 · Meril Life Sciences Private Limited · May 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