Cleared Traditional

K150232 - Radifocus Optitorque Angiographic Catheter

K150232 is an FDA 510(k) clearance for Radifocus Optitorque Angiographic Catheter, manufactured by Ashitaka Factory of Terumo Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K150232 · Ashitaka Factory of Terumo Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
259d
Days
Class 2
Risk

K150232 is an FDA 510(k) clearance for the Radifocus Optitorque Angiographic Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Ashitaka Factory of Terumo Corp. (Fujinomiya Shizuoka, JP). The FDA issued a Cleared decision on October 19, 2015 after a review of 259 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Ashitaka Factory of Terumo Corp. devices

FDA 510(k) Submission Details - K150232

510(k) Number K150232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date October 19, 2015
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 356
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K150232.
Torcon NB Advantage Catheters
K161822 · Cook Incorporated · Oct 2016
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
K161287 · Medtronic Vascular · Aug 2016
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605 · Boston Scientific Corporation · Oct 2015
AngioDynamics Mariner Angiographic Catheters
K151724 · AngioDynamics, Inc. · Oct 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · Cook, Inc. · Jan 2015
MODIFIED CONCENTRIC MICROCATHETER
K131437 · Concentric Medical, Inc. · Oct 2013